Devices › Pump, infusion, enteral
Device brand name · 80 lzh pump infusion enteral
Clearstar Pump: medical device reports filed with FDA
982 reports name it, 2007–2014. Manufacturer given most often on reports: Ross Products Division. Product code LZH.
- 982
- device reports naming the brand
- 0% of all MAUDE reports · about 51 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98.9%
- classified as malfunction
- 95.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 982 reports that name the brand "Clearstar Pump" (80 lzh pump infusion enteral), received between May 2007 and July 2014; the manufacturer given most often on reports is Ross Products Division. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (98.9%) and injury (1.1%); across all pump, infusion, enteral reports (product code LZH) death is recorded in 0.6% and malfunction in 95.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are component(s), broken (79.5%), insufficient flow or under infusion (8.5%) and underdelivery (5.8%). The patient problems coded most often are underdose, no patient involvement and vomiting. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Clearstar Pump was received in the five years to August 2026; the latest was received in July 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 14,924 reports carrying product code LZH. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Component(s), broken | 781 | 79.5% | 11.3% |
| Insufficient flow or under infusion | 83 | 8.5% | 3.6% |
| Underdelivery | 57 | 5.8% | 1.4% |
| Excess flow or over-infusion | 18 | 1.8% | 6.3% |
| Breakthe device broke | 14 | 1.4% | 0.9% |
| Crackthe device cracked | 10 | 1% | 0.2% |
| Inaccurate delivery | 8 | 0.8% | 2.6% |
| Overdelivery | 8 | 0.8% | 2.2% |
| Device alarm system | 5 | 0.5% | 3.6% |
| False alarm | 3 | 0.3% | 0.2% |
| Fire | 1 | 0.1% | 0.2% |
| Fitting problem | 1 | 0.1% | 0% |
| Inappropriate/inadequate shock/stimulation | 1 | 0.1% | 0% |
| Insufficient device problem information | 1 | 0.1% | 0.2% |
| Motor failure | 1 | 0.1% | 0% |
| No display/image | 1 | 0.1% | 5.6% |
| No flow | 1 | 0.1% | 0.2% |
| Other (for use when an appropriate device code cannot be identified) | 1 | 0.1% | 0.3% |
| Overfill | 1 | 0.1% | 0% |
| Pumping stopped | 1 | 0.1% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Underdoseless than the intended dose | 17 | 1.7% |
| No patient involvement | 10 | 1% |
| Vomitingbeing sick | 6 | 0.6% |
| Hypoglycemialow blood sugar | 3 | 0.3% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 0.3% |
| Overdosea dose above the recommended amount | 3 | 0.3% |
| Dehydrationdehydration | 2 | 0.2% |
| Abdominal cramps | 1 | 0.1% |
| Abdominal distention | 1 | 0.1% |
| Abdominal painstomach or belly pain | 1 | 0.1% |
| Aspiration/inhalation | 1 | 0.1% |
| Bloating | 1 | 0.1% |
| Electric shockan electric shock | 1 | 0.1% |
| Loss of consciousnesspassing out | 1 | 0.1% |
| Nauseafeeling sick | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Clearstar Pump | Product code LZH | All MAUDE reports |
|---|---|---|---|
| Reports | 982 | 14,924 | 26,136,888 |
| Share of that pool | — | 6.6% | 0% |
| Classified as death, per 1,000 reports | 0 | 6 | 9 |
| Classified as injury | 1.1% | 2.6% | 36.2% |
| Classified as malfunction | 98.9% | 95.5% | 62.3% |
| Filed by the manufacturer | 100% | 95% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LZH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Kangaroo | 4,328 | 117 | 0.2% |
| Enteralite Infinity Enteral Feeding Pump | 2,930 | 233 | 0.2% |
| Epump 1000ml Safety Screw Spik | 1,111 | 0 | 0% |
| Embrace Pump | 958 | 0 | 0% |
| Kangaroo Epump - New | 656 | 0 | 0.2% |
| Kangaroo Joey Pump W/Pole Clmp | 571 | 0 | 0.4% |
| Enteralite Infinity Enteral Infusion Pump | 202 | 3 | 0% |
| Cadd-Legacy Duodopa Ambulatory Infusion Pump | 203 | 0 | 0.5% |
| Kangaroo Joeypump W/Pole Clmp | 150 | 0 | 0% |
| Kangaroo Epump - Rfb | 151 | 0 | 0% |
| Cadd Legacy Pump | 1,160 | 4 | 0.2% |
| Infinity | 193 | 24 | 2.1% |
| Cadd Legacy | 504 | 0 | 0% |
| Quantum | 183 | 35 | 0.5% |
| Cadd-Legacy Pump | 389 | 0 | 0.3% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Clearstar Pump reports
How many FDA reports name Clearstar Pump?
982 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (98.9%) and injury (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
component(s), broken (79.5%), insufficient flow or under infusion (8.5%), underdelivery (5.8%), excess flow or over-infusion (1.8%) and break (1.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Clearstar Pump was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.