BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACE PUMP IV SET

    MDR report key: 3222065 · Received July 5, 2013

    Report

    Report Number
    9614279-2013-00014
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Report Date
    June 14, 2013
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVAL COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE PRODUCT CATALOG NUMBER IDENTIFIED IN THE REPORTED EVENT. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS SEVERAL INCIDENCES OF ASV VALVE DISCONNECTING FROM TUBING, BUT REMAINING STUCK IN CARESITE. ONE CAUSED A CHEMO SPILL. NO SAMPLES WERE SAVED. FOLLOW-UP CORRESPONDENCE RECEIVED FROM THE SALES REP INDICATED THERE WAS NO HARM TO THE PT OR STAFF, AND NO INTERVENTION WAS NEEDED AS A RESULT OF THIS INCIDENT. THE ASV VALVE WAS ABLE TO BE DISCONNECTED FROM THE TUBING SET, BUT COULD NOT BE DISCONNECTED FROM THE CARESITE VALVE. THE FACILITY IS CONCERNED WITH NOT BEING ABLE TO REMOVE THE VALVE IN AN EMERGENCY SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307083 SPACE PUMP IV SET UNIV. 15DROP PUMP SET, 3 ULTRASITE, ASV FPA B. BRAUN DOMINICAN REPUBLIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other