BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAEMONETICS

    MDR report key: 1983679 · Received February 6, 2011

    Report

    Report Number
    MW5019330
    Event Type
    Malfunction
    Date Received
    February 6, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 6, 2011
    Manufacturer
    HAEMONETICS CORP
    Product Code
    GKT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HELLO. THE PRODUCT MALFUNCTION DEALS WITH THE HAEMONETICS PS2 PLASMAPHERESIS MACHINES. THE EVENT OCCURRED AT (B)(6). THE MALFUNCTION WAS THE BOWL THAT THE BLOOD FLOWS INTO AND THEN IS SPUN AND THE PLASMA FLOWS OUT OF BREAKING. THE BREAKAGE WAS INSIDE THE PART ITSELF AND NO BLOOD CAME OUT OF THE CONTAINED SYSTEM. HOWEVER, I WAS TOLD THAT MY RED BLOOD CELLS COULD NOT BE RETURNED TO ME AS THEY WERE CONTAMINATED. CONTAMINATED BY WHAT I HAVE NO IDEA. THE BOWL WAS ALMOST FULL AND THEY TOLD ME THAT I WOULD NOT BE ABLE TO DONATE AGAIN FOR 56 DAYS BECAUSE IT COUNTS THE SAME AS DONATING WHOLE BLOOD. ONE OF THEIR POLICIES IS COMPLETELY RIDICULOUS HERE AS THERE IS NO APPARENT REASON THAT THE MACHINE COULD NOT HAVE BEEN SET TO RETURN AND LET ME GET MY CELLS BACK. AS FOR THE MACHINES THEMSELVES, THIS KIND OF INCIDENT IS FAIRLY COMMON AND RESULTS BECAUSE THE MACHINES WERE DESIGNED MORONICALLY. THE DESIGN FLAW LIES IN PUTTING THE SPINNER/CENTRIFUGE INSIDE THE BLOOD COLLECTION RECEPTACLE. THE OLD BAXTER MACHINES HAD THE TWO PARTS SEPARATED AND THIS TYPE OF PROBLEM COULD NOT HAPPEN WITH THEM. IF THE SPINNER BROKE ON THE BAXTER MACHINES THEN THE WORKERS COULD JUST FLUSH IT OUT AND THEN REPLACE IT WITH A DIFFERENT SPINNER AND CONTINUE THE DONATION WITH NO LOSS OF CELLS TO THE DONOR. THE HAEMONETICS MACHINES EVEN HAVE A BAG ATTACHED TO THE BACK OF THE MACHINE FOR I WOULD GUESS IF THE BOWL ACTUALLY SHATTERED INSIDE THE MACHINE. THERE WAS NO CHANCE OF THAT WITH THE BAXTER MACHINES EITHER AS NEITHER THE RECEPTACLE NOR THE SPINNER WERE INSIDE OF THE MACHINE. THE HAEMONETIC MACHINES REALLY SHOULD NOT HAVE EVER RECEIVED APPROVAL FOR USE IN THE PLASMA CENTERS DUE TO THESE OBVIOUS DESIGN FLAWS. AS I AM (B)(6) TALL AND WEIGH (B)(6) THE BLOOD LOSS IS NOT REALLY GOING TO AFFECT ME AS MUCH AS THE MONETARY LOSS OF (B)(6) OF DONATIONS. THAT IS (B)(6) AT MY WEIGHT. HOWEVER, DONORS CAN WEIGH AS LITTLE AS (B)(6) AND THE LOSS OF THE RED CELLS FOR THEM MAY HAVE MUCH MORE OF AN EFFECT. THE HAEMONETICS MACHINES TAKE THE SAME AMOUNT OF BLOOD TO FILL THE BOWL REGARDLESS OF THE DONOR'S WEIGHT. THE OLD BAXTER MACHINES ALSO TOOK THE SAME AMOUNT OF BLOOD FROM EVERY DONOR REGARDLESS OF WEIGHT, BUT THE RECEPTACLE WAS SMALLER. PLEASE DO SOMETHING TO GET THESE HAEMONETIC MACHINES OFF THE MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMONETICS PS2 GKT HAEMONETICS CORP DO NOT KNOW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other