BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS2

    MDR report key: 2211648 · Received August 5, 2011

    Report

    Report Number
    1219343-2011-00113
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 13, 2011
    Report Date
    August 5, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    PMA / PMN Number
    BK040025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6), 2011 AND ALLEGED POSSIBLE HEMOLYSIS ON THE PLASMA COLLECTION SYSTEM DURING THE LAST DRAW CYCLE. THE OPERATOR NOTED THE PLASMA WAS A RED COLOR AND AN ALARM CODE 206, RATIO FAULT TOO HIGH MESSAGE. NO CELLS WERE RETURNED TO THE DONOR AFTER DISCOVERY BY THE OPERATOR. NO DONOR INJURY OR REACTION REPORTED. NO OPERATOR INJURY REPORTED. THE DEVICE WAS EVALUATED IN THE FIELD BY THE CUSTOMER'S TECHNICIAN AND FOUND TO MEET PERFORMANCE SPECIFICATIONS. AT THIS TIME THE CUSTOMER COULD NOT PROVIDE A DATE OF THIS SERVICE. WE HAVE REVIEWED THE ERROR CODE AND DETERMINED IT TO BE AN ISOLATED OCCURRENCE THAT IS UNRELATED TO THE POSSIBLE HEMOLYSIS. NO DISPOSABLE SAMPLES WERE AVAILABLE FOR EVALUATION. NO NON-CONFORMITIES FOUND IN THE REVIEW OF HISTORICAL RECORDS FOR THE DISPOSABLES. THE SOLUTIONS USED DURING THE PROCEDURE WERE NOT MADE BY OR FOR HAEMONETICS. HEMOLYSIS WAS NOT CONFIRMED BY THE CUSTOMER. NO BLOOD SAMPLE WAS AVAILABLE FOR ANALYSIS. THE OPERATOR MADE THEIR DETERMINATION OF HEMOLYSIS BASED ON EXPERIENCE. THE RETURN OF HEMOLYZED CELLS IS DEPENDENT ON AN OPERATOR'S AWARENESS OF THE ISSUE AND TERMINATING THE PROCEDURE PRIOR TO RETURNING CELLS. THE IMPACT OF HEMOLYZED CELLS ON A HEALTHY DONOR COULD RANGE FROM NO SYMPTOMS TO ACUTE. AS THE OPERATOR TERMINATED THE PROCEDURE, THERE IS NO POTENTIAL INJURY TO THE DONOR FROM HEMOLYSIS. NO INJURY WAS REPORTED BY THE CENTER. NO OPERATOR INJURY REPORTED. AS THE PROCEDURE WAS TERMINATED, THE DONOR EXPERIENCED A RED CELL LOSS. AS THE DONOR PASSED THE HEALTH CRITERIA TO DONATE, THERE IS A VERY LOW RISK OF ANEMIA REQUIRING MEDICAL INTERVENTION. THIS CONDITION WOULD NOT BE CONSIDERED POTENTIALLY SERIOUS. IF MORE INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCS2 PLASMA COLLECTION SYSTEM GKT HAEMONETICS CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI