BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDEHP Y-BLOOD SET W/FILTER PUMP 203CM

    MDR report key: 2043231 · Received February 24, 2011

    Report

    Report Number
    9615050-2011-00112
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 27, 2011
    Manufacturer
    HOSPIRA COSTA RICA 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 CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE DEVICE HAS A COMMON DEVICE NAME OF 80FPA AND A 510K OF K101677. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED NO FLOW. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED VOLUME OF ALBUMIN. IT WAS REPORTED THAT THE TUBING SET WAS PRIMED WITH ALBUMIN, THE SECURE LOCK MALE ADAPTER WAS CONNECTED TO THE PT'S IV ACCESS SITE, AND THE DELIVERY WAS STARTED. IT WAS REPORTED THAT THE ANESTHETIST SQUEEZED THE BLOOD PUMP CHAMBER IN THE TUBING SET TO DELIVER THE ALBUMIN. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE CUSTOMER CONTACT REPORTED A BALL VALVE IN THE BLOOD PUMP CHAMBER WAS "STUCK CLOSED" AND NO FLOW WAS NOTED. THE TUBING 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 ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NDEHP Y-BLOOD SET W/FILTER PUMP 203CM UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1