AT3 Autotransfusion Set 9005444Recalls & reported problems
Fresenius Kabi AG · AT3 Autotransfusion Set is a disposable for CATS containing a washing chamber, tubing, waste bag and reinfusion bag. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04052682000867), received between May 10, 2018 and May 10, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Displays Incorrect Message1
- Device Inoperable1
- Use of Device Problem1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 10, 2018Device Inoperable; Use of Device Problem; Device Displays Incorrect Message
FRESENIUS CONTINUOUS AUTOTRANSFUSION SYSTEM (CATS) UNIT STOPPED WORKING AT BEGINNING OF USE, WAS NOT ABLE TO FINISH A CYCLE. AFTER INITIATING USE, THE UNIT DISPLAYED A "BLOOD IN" AND "BLOOD FLOW" ERROR. UNIT WAS REMOVED FROM SERVICE AND BROUGHT TO CLINICAL ENGINEERING FOR INSPECTION. MANUFACTURER WAS CALLED IN AND AFTER TROUBLESHOOTING THE UNIT FOUND A PROBLEM WITH THE AT3 AUTOTRANSFUSION SET. THE MANUFACTURER'S ENGINEER FOUND THE SET TUBING THAT GOES TO THE HTC SENSOR NOT LONG ENOUGH (A POSSIBLE MANUFACTURING ERROR) TO ALLOW THE SENSOR TO REACH ITS PROPER PLACEMENT IN THE CAT UNIT, HAVING THE USER TO PULL ON THE TUBING IN ORDER TO MAKE IT REACH. WHILE THE USER PULLED ON THE TUBING, INADVERTENTLY DECREASED THE TUBING INTERNAL SIZE, PREVENTING THE BLOOD TO FLOW THROUGH IT, THUS CAUSING THE SYSTEM ERROR AND STOPPING OPERATION. THE AT3 PART NUMBER IS (B)(4) AND THE LOT NUMBER IS FIT 063. A NEW AT3 FROM A DIFFERENT LOT WAS USED TO TEST THE CAT UNIT AND THE SYSTEM WORKED FINE, ACCORDING TO MANUFACTURER'S SPECIFICATIONS. MANUFACTURER RESPONSE FOR AT3 CONTINUOUS AUTOTRANSFUSION SET, AT3 AUTOTRASFUSION SET (PER SITE REPORTER). MANUFACTURER FIELD ENGINEER CHECKED UNIT AND CONCLUDED PROBLEM
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7501883 ↗
Other Apparatus, Autotransfusion devices
- OASIS 3650-100Atrium Medical Corporation · APPARATUS, AUTOTRANSFUSION2 recalls22 reports
- EXPRESS 4050-100NAtrium Medical Corporation · APPARATUS, AUTOTRANSFUSION2 recalls2 reports
- NA ATL2001Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 death79 reports
- autoLog IQ™ ATLGIQMedtronic, Inc. · APPARATUS, AUTOTRANSFUSION58 reports
- OCEAN 2050-000Atrium Medical Corporation · Apparatus, Autotransfusion1 recall2 reports
- NA BTC93Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 recall2 reports
- NA BTC98Medtronic, Inc. · APPARATUS, AUTOTRANSFUSION1 recall0 reports
- HAEMONETICS CELL SAVER ELITE SYSTEM CSE-P-125Haemonetics Corporation · Apparatus, Autotransfusion47 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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