BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACE PUMP IV SET

    MDR report key: 3210074 · Received June 27, 2013

    Report

    Report Number
    9614279-2013-00012
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 4, 2013
    Manufacturer
    B. BRAUN OF 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. (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 ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY. REPORTS LABOR AND DELIVERY PT BEGAN TO CRASH, DECIDED NEEDED TO FREE FLOW IV SOLUTIONS WIDE OPEN, BUT COULD NOT REMOVE ASV FROM SET. HAD TO RE-SPIKE CONTAINER WITH NEW SET THAT DID NOT HAVE ASV VALVE ATTACHED. NO INJURY TO PT, BUT THIS DID CAUSE A DELAY. SAMPLE WAS NOT SAVED. REPORTER INDICATED INCIDENCES LIKE THIS ARE OCCURRING 2-3 TIMES PER DAY IN LABOR AND DELIVERY UNIT, OFTEN WHILE ONLY NORMAL SALINE OR LACTATED RINGERS BEING INFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293360 SPACE PUMP IV SET UNIV. 15DROP PUMP SET, 3 ULTRASITE, ASV FPA B. BRAUN OF DOMINICAN REPUBLIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other