BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIBORE EXT SET 60IN NDEHP

    MDR report key: 2063185 · Received March 22, 2011

    Report

    Report Number
    9613251-2011-00033
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 24, 2011
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPK AND A 510K OF K063239. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A DELAY IN CRITICAL THERAPY FOLLOWING A LEAK. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF MILRINONE, AT AN UNSPECIFIED RATE, VIA A SYRINGE PUMP. THE FEMALE ADAPTER OF THE TUBING SET WAS CONNECTED TO A 20ML BD SYRINGE AND MALE LUER LOCK WITH SPIN COLLAR WAS CONNECTED TO THE PT'S IV ACCESS SITE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED THAT THE PT'S BLOOD PRESSURE WAS NOT RESPONDING TO THE MILRINONE THERAPY. IT WAS REPORTED THAT THE NURSE THEN INCREASED THE DELIVERY RATE OF THE MILRINONE. AT AN UNSPECIFIED TIME LATER, THE NURSE NOTED LEAKING AT THE CONNECTION OF THE TUBING SET AND THE SYRINGE. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. IT WAS REPORTED THAT THE PT'S BLOOD PRESSURE DID RESPOND; HOWEVER, SPECIFIC BLOOD PRESSURE VALUES WERE NOT PROVIDED. ALTHOUGH THERE WAS A POTENTIAL FOR SERIOUS INJURY, THERE WERE NO REPORTED ADVERSE PT EFFECTS. ALTHOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIBORE EXT SET 60IN NDEHP UNK FPA HOSPIRA LTD. NA 94359NS

    Patients

    Seq Age Sex Outcome Treatment
    1 20ML SYRINGE: MFG BY BECTON, DICKSON AND COMPANY