Apparatus, autotransfusion: medical device reports filed with FDA

3,172 reports carry this product code, 1992–2026; 5 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.

3,172
reports with this product code: 0% of all MAUDE reports; 107
reports, 12 months to August 2026: 169 in the 12 months before; 80.1%
classified as malfunction: 62.3% across all reports; 2.6%
classified as death, as reported: 0.9% across all reports

Product code CAC is FDA's classification for "Apparatus, autotransfusion" (anesthesiology panel), a class 2 device. 3,172 medical device reports carry this product code, 0% of the MAUDE database, from April 1992 to August 2026.

107 reports arrived in the 12 months to August 2026, down 37% from 169 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 (80.1%), injury (14%) and death (2.6%). 5 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
Orthopat Perioperative Autotransfusion System	1,016	0	0.1%	99.5%
autoLog Wash Kit	160	46	0.6%	86.9%
Argyle	2	60	1%	82.4%
Extraction Bag For Mis	1	9	0%	90.1%
Stryker	1	5	1.3%	46.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Haemonetics	1,333	42%
Atrium Medical	278	8.8%
Perfusion Systems	162	5.1%
Davol	126	4%
Medtronic Mexico	99	3.1%
Sorin Group Italia	59	1.9%
Stryker Instruments	32	1%
Davol Sub C R Bard	28	0.9%
Zimmer Surgical	20	0.6%
Terumo Bct	19	0.6%
Teleflex Medical	13	0.4%
Medtronic Mexico S De R L De Cv	11	0.3%
Sorin Group Deutschland	5	0.2%
Bard	3	0.1%
Stryker	3	0.1%

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

Death2.6%83

Injury14%444

Malfunction80.1%2,542

Other2.4%75

Not given0.9%28

Who filed

Manufacturer report90.5%2,871

Voluntary report4.1%129

User facility report0%0

Distributor report0.3%8

Not given5.2%164

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

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	387	12.2%
Device contamination with body fluid	334	10.5%
Nonstandard device	177	5.6%
Breakthe device broke	173	5.5%
Leak/splashthe device leaked	162	5.1%
Device operates differently than expectedthe device behaved unexpectedly	148	4.7%
Crackthe device cracked	133	4.2%
Failure to power up	103	3.2%
Insufficient device problem information	92	2.9%
Mechanical problema mechanical problem	89	2.8%
Loss of powerthe device lost power	87	2.7%
Device displays incorrect message	83	2.6%
Detachment of device component	77	2.4%
Noise, audible	76	2.4%
Device emits odor	73	2.3%
Device inoperablethe device could not be used	68	2.1%
Infusion or flow problema problem with flow or infusion	60	1.9%
Other (for use when an appropriate device code cannot be identified)	59	1.9%
Disconnection	56	1.8%
Moisture damage	53	1.7%

Questions about apparatus, autotransfusion reports

What is product code CAC?

FDA's classification code for "Apparatus, autotransfusion", class 2, reviewed by the anesthesiology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,172 reports through August 2026, 107 of them in the latest 12 months.

Which brands appear most often?

Orthopat Perioperative Autotransfusion System (1,016), autoLog Wash Kit (160), Argyle (2), Extraction Bag For Mis (1) and Stryker (1). 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.