BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBC FLOPUMP

    MDR report key: 5008473 · Received August 13, 2015

    Report

    Report Number
    1645362-2012-00001
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    August 13, 2012
    Report Date
    August 13, 2015
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORP.
    Product Code
    KFM
    PMA / PMN Number
    K983272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2015, IBC RECEIVED A COMPLAINT FORM A DISTRIBUTOR (B)(4) STATING THAT A FLOPUMP PRODUCT (SERIAL NUMBER (B)(4)) HAD A MALFUNCTION DURING SURGERY. SPECIFICALLY, THE CUSTOMER STATED THAT THE COVER OF THE PUMP DETACHED FROM THE BODY OF THE PUMP DURING SURGERY. THE CUSTOMER DID NOT CLARIFY WHETHER THE DEVICE WAS BEING USED ON A PATIENT, OR WAS BEING PRIMED. UPON RETURN OF THE PRODUCT AT IBC, AN INVESTIGATION WAS CONDUCTED. LUMINOL TESTING WAS PERFORMED ON THE PUMP, WHICH INDICATED THAT THERE WAS NO DETECTABLE BLOOD RESIDUE. THEREFORE, IBC HAS CONCLUDED THAT THE DEVICE WAS ONLY USED DURING PRIMING AND WAS NOT USED ON A PATIENT. INVESTIGATION INTO THE PRODUCT CONFIRMED THE PROBLEM, HOWEVER THE ROOT CAUSE COULD NOT BE ESTABLISHED. TWO POTENTIAL CAUSES FOR THE ISSUE INCLUDE AGGRESSIVE DE-BUBBLING TECHNIQUE DURING PRIMING, AND HUMAN ERROR DURING MANUFACTURING ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMED THAT THE HOUSING FOR THE FLOPUMP PRODUCT CAME LOOSE DURING A SURGERY, CAUSING BLOOD LOSS TO THE PATIENT. THERE WAS NO INDICATION AS TO THE PATIENT CONDITION AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535158 IBC FLOPUMP FLOPUMP, KFM INTERNATIONAL BIOPHYSICS CORP. 6000S(KIT) 113011-2252

    Patients

    Seq Age Sex Outcome Treatment
    1