BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMA

    MDR report key: 2171902 · Received April 13, 2006

    Report

    Report Number
    8010182-2006-00004
    Event Type
    Other
    Date Received
    April 13, 2006
    Date of Event
    January 24, 2006
    Report Date
    April 12, 2006
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ABSENCE OF INCRIMINATED SAMPLE FOR INVESTIGATION. ABSENCE OF FURTHER INFO FROM THE CLINIC INVOLVED. INCIDENT STILL UNDER INVESTIGATION. A F/U REPORT WILL BE ESTABLISHED AND FORWARDED TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THEY HAVE A COUPLE OF CONCERNS ASSOCIATED WITH THIS REPORT. THE CUSTOMER STATED THAT BLOOD EXPLODED FROM THE BLOOD PUMP TUBING SEGMENT OF THE DISPOSABLE SET PART NO (B)(4) LOT 05J1981G DURING TREATMENT. THE BLOOD SHOT OUT OF THE SET AND SPAYED THE WALL, MACHINE, AND WAS PULLING ON THE FLOOR... THE CUSTOMER DID NOT KNOW HOW LONG THE TREATMENT HAD BEEN GOING ON FOR BUT (B)(6) (OUR FIELD SVC TECH) SAID THAT THE MACHINE HAD ABOUT 8 HOURS OF INFO ON THE SCREEN. HE (B)(6) ALSO INDICATED THAT HE RAN THE MACHINE AND IT SEEMED TO BE FUNCTIONING PROPERLY. THE PT WAS NOT INJURED BUT WAS GOING THROUGH TESTS TO SEE IF HE NEEDED A BLOOD TRANSFUSION. THE RESULTS WERE NOT KNOWN AT THE TIME THE CALL WAS PLACED TO GAMBRO. THE CUSTOMER WAS VERY CONCERNED BECAUSE THE MACHINE DID NOT ALARM IN A MANNER THAT WOULD NOTIFY THE NURSE THAT SOMETHING POTENTIALLY LIFE THREATENING WAS OCCURRING. THANKFULLY, THE NURSE HAPPENED TO WALK BY AND SEE THE BLOOD SHOOTING OUT OF THE MACHINE AND TOOK THE APPROPRIATE STEPS TO GET THE PT OFF THE MACHINE. THE CUSTOMER FEELS THAT SERIOUS HARM COULD HAVE COME TO THE PT HAD THE NURSE NOT WALKED IN WHEN SHE DID. WHEN ASKED HOW MUCH BLOOD WAS LOST, THE CUSTOMER SAID "A LOT." MY GUESS WOULD BE BETWEEN 300 TO 500 CC OF BLOOD. CUSTOMER DOES HAVE THE SAMPLE BUT DOES NOT WANT TO KEEP IT BECAUSE IT IS COMPLETELY FULL OF BLOOD. I INFORMED THE CUSTOMER THAT THEY SHOULD DISINFECT THE SET AND SEND IT BACK TO GAMBRO. NO REPLACEMENT WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA PRISMA M100 PRESET FJK GAMBRO INDUSTRIES M100 05J1981G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other