FDA Adverse Event Other Summary report: N

COBE BRAT 2

MDR report key: 871314 · Received June 21, 2007

Report

Report Number
MW5002789
Event Type
Other
Date Received
June 21, 2007
Date of Event
June 20, 2007
Report Date
June 21, 2007
Manufacturer
COBE CARDIOVASCULAR INC.
Product Code
CAC
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

WE HAVE HAD SEVERAL INCIDENTS OF THE BRAT 2 UNITS FAILING TO PROPERLY WASH HEPARIN FROM BLOOD SCAVENGED OFF THE SURGICAL SITE. THERE WERE QUESTIONS AS TO WHETHER THIS WAS CAUSED BY A DEVICE FAILURE OR DUE TO OTHER CIRCUMSTANCES. WE FOUND THAT THIS WAS CAUSED BY THE USER FAILING TO OPEN THE CLAMP BELOW THE WASH BAG, THUS CUTTING OFF A WASH FLUID SUPPLY TO THE BRAT 2. THIS MORNING TESTS RESULTS FOUND THAT THE BRAT 2 DOES NOT HAVE A GOOD MECHANISM IN PLACE FOR DETECTING A LACK OF WASH FLUID SUPPLY. THERE IS AN AIR DETECTOR THAT IS IN LINE WITH INCOMING WASH FLUID WHICH DETECTS WHETHER OR NOT THE TUBE IS EMPTY OR NOT, OR FILLED WITH BUBBLES. HOWEVER, THIS LINE IS ALSO THE LINE USED TO FILL THE BOWL WITH BLOOD PRIOR TO THE WASH CYCLE. THEREFORE, IF THE WASH FLUID SUPPLY IS CLAMPED, AND THERE IS STILL RESIDUAL BLOOD IN THE FILL LINE AT THE POINT OF THE AIR DETECTOR -WHICH WOULD BE LIKELY GIVEN NO WASH HAD YET OCCURRED-, THE AIR DETECTOR STILL SEES FLUID -ALTHOUGH IT IS BLOOD, NOT WAS FLUID- AND DOESN'T REALIZE THERE IS A PROBLEM. THE BLOOD IN THE LINE WOULD TRICK THE UNIT INTO THINKING THAT THERE WAS WASH FLUID FLOWING DURING THE WASH CYCLE, EVEN THOUGH IT WAS CLAMPED OFF AT THE BAG. THIS WOULD PREVENT THE HEPARIN FROM BEING WASHED OUT OF THE SPUN BLOOD. COBE TECHNICAL SERVICE REPRESENTATIVE WAS CONTACTED AND HE AGREED THAT THIS IS THE CASE. HE SAID THAT JUST AS BUBBLES AT THE AIR DETECTOR CAN TRICK THE UNIT INTO THINKING THAT THE UNIT IS EMPTY, RESIDUAL FLUID IN THE LINE AT THE POINT OF THE AIR DETECTOR CAN CAUSE IT TO THINK THERE IS FLUID FLOWING. THIS IS A CONDITION THAT ALL BRAT 2 USERS SHOULD BE AWARE OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 COBE BRAT 2 AUTOLOGOUS BLOOD TRANSFUSION CAC COBE CARDIOVASCULAR INC. BRAT 2

Patients

Seq Age Sex Outcome Treatment
1 YR Other