BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF MIF MAC EXT (CAS/48)

    MDR report key: 1934381 · Received November 23, 2010

    Report

    Report Number
    9613251-2010-00163
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    FPB
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. 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 SEPARATION. THE EXTENSION SET WAS CONNECTED TO AN UNSPECIFIED SYRINGE PUMP TUBING SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF TPN. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE NURSE NOTED A LEAK OF SOLUTION AT THE INLET OF THE FILTER AND BLEED BACK IN THE DISTAL END OF THE EXTENSION SET. THE NURSE STOPPED THE DELIVERY AND CLAMPED THE EXTENSION SET. IT WAS REPORTED WHILE THE NURSE WAS EXAMINING THE EXTENSION SET FOR THE LOCATION OF THE LEAK, THE TUBING SEPARATED FROM THE FILTER INLET. THE EXTENSION SET WAS REPLACED AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF MIF MAC EXT (CAS/48) 80FPB FPB HOSPIRA, LTD. NA 810794W

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA