BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFELINE HORIZON PUMP IV SET

    MDR report key: 1030833 · Received April 17, 2008

    Report

    Report Number
    9614279-2008-00013
    Event Type
    Other
    Date Received
    April 17, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 9, 2008
    Manufacturer
    B. BRAUN OF DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K904518
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED PUMP SET SAMPLE WAS RETURNED TO THE MFR TO BE EVALUATED. THE SET WAS SEVERED IN TWO PIECES IN THE PROXIMITY OF THE FREE FLOW PROTECTION CLIP DUE TO A PERPENDICULAR SLIT IN THE TUBING IN THE PROXIMITY OF THE SLIDE CLAMP. THE SLIDE CLAMP WAS RETURNED LYING LOOSE IN THE BAG. THE SLIDE CLAMP WAS EXAMINED, AND DID NOT HAVE ANY SHARP EDGES, AND THE TUBING DID NOT APPEAR TO BE STRETCHED. THE SLIDE CLAMP WAS PLACED ON OTHER AREAS OF THE RETURNED SET, AND NO CUTTING OF THE TUBING OR DAMAGE WAS NOTED ON THE TUBING, AFTER MULTIPLE PASSES WERE MADE WITH THE SLIDE CLAMP. THE SLIT DID NOT APPEAR TO BE RELATED TO ANY MFG DEFECT OF THIS PART. HOWEVER, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED PART.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: ETOPOSIDE (CHEMO DRUG) BEING INFUSED. NURSE NOTICED LEAKING- OPENED PUMP DOOR- FREE FLOW PROTECTOR CAME OFF AND SET FELL APART. NO ADD'L INFO WAS PROVIDED BY THE FACILITY AFTER SEVERAL ATTEMPTS WERE MADE. THE LOT NUMBER REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFELINE HORIZON PUMP IV SET HORIZON PUMP SET FPA B. BRAUN OF DOMINICAN REPUBLIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other