BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Y-SHAPED BLOOD SET W/ PUMP

    MDR report key: 3390957 · Received September 12, 2013

    Report

    Report Number
    9615050-2013-02994
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    August 16, 2013
    Report Date
    August 16, 2013
    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
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REC'D. INVESTIGATION IS NOT COMPLETE. ADDITIONAL DEVICE INFO: THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON 510K OF K101677. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED PARTICULATE. THE TUBING SET WAS TO BE USED TO DELIVER A UNSPECIFIED MEDICATION. IT WAS REPORTED PRIOR TO PRIMING THE TUBING SET, PARTICULATE WAS NOTED ON THE BLOOD FILTER OF THE TUBING SET. IT WAS REPORTED THAT THE PARTICULATE WAS DESCRIBED AS A FIBER LIKE SUBSTANCE. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY 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
    460373 Y-SHAPED BLOOD SET W/ PUMP UNK FPA HOSPIRA COSTA RICA LTD. NA 231105G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA