Warmer, blood, non-electromagnetic radiation: medical device reports filed with FDA

2,220 reports carry this product code, 1998–2026; 10 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,220
reports with this product code: 0% of all MAUDE reports; 92
reports, 12 months to August 2026: 251 in the 12 months before; 96.8%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

Product code BSB is FDA's classification for "Warmer, blood, non-electromagnetic radiation" (hematology panel), a class 2 device. 2,220 medical device reports carry this product code, 0% of the MAUDE database, from February 1998 to August 2026.

92 reports arrived in the 12 months to August 2026, down 63% from 251 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 (96.8%), injury (1.2%) and death (1%). 10 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Level 1 Fast Flow Fluid Warmer	612	29	0.8%	98.9%
Level 1	140	0	0.5%	97.8%
Level 1 Hotline Fluid Warmer	13	1	0%	100%
Ranger	9	151	1.2%	52.7%
Level 1 Hotline Fluid Warmer 390	3	11	0%	100%
Level 1 Hotline Blood And Fluid Warmer	2	17	0%	99.5%
Level 1 Hotline Low Flow System	2	0	0%	100%
Prismaflex	2	4	7.7%	56.9%
Cadd Cassette Reservoirs - Flow Stop	1	0	0.2%	99.7%
Superdimension Inreach Bronchus System	1	0	14.1%	15%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Smiths Medical Asd	559	25.2%
Oakdale	498	22.4%
St Paul	350	15.8%
3m Health Care	280	12.6%
3m	156	7%
Smith S Medical Asd	58	2.6%
Icu Medical	57	2.6%
Icu Medical Healthcare Manufacturing De C V	4	0.2%
Smiths Medical	3	0.1%
Nellcor Puritan Bennett	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1%23

Injury1.2%27

Malfunction96.8%2,150

Other0.8%18

Not given0.1%2

Who filed

Manufacturer report96%2,132

Voluntary report2%44

User facility report0%0

Distributor report0%0

Not given2%44

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	544	24.5%
Device alarm system	238	10.7%
Temperature problem	135	6.1%
Pressure problem	116	5.2%
Leak/splashthe device leaked	90	4.1%
Insufficient heating	82	3.7%
Insufficient flow or under infusion	81	3.6%
Insufficient device problem information	73	3.3%
Overheating of device	64	2.9%
Breakthe device broke	45	2%
Defective component	39	1.8%
False alarm	38	1.7%
Failure to power up	36	1.6%
Defective alarm	35	1.6%
Excessive heating	35	1.6%
Failure to pump	35	1.6%
Device markings/labelling problema problem with the device markings or label	34	1.5%
Crackthe device cracked	33	1.5%
Infusion or flow problema problem with flow or infusion	33	1.5%
Device sensing problem	31	1.4%

Questions about warmer, blood, non-electromagnetic radiation reports

What is product code BSB?

FDA's classification code for "Warmer, blood, non-electromagnetic radiation", class 2, reviewed by the hematology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,220 reports through August 2026, 92 of them in the latest 12 months.

Which brands appear most often?

Level 1 Fast Flow Fluid Warmer (612), Level 1 (140), Level 1 Hotline Fluid Warmer (13), Ranger (9) and Level 1 Hotline Fluid Warmer 390 (3). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.