BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 1959864 · Received January 7, 2011

    Report

    Report Number
    9615050-2011-00010
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 3, 2010
    Report Date
    December 8, 2010
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CATALOG NUMBER WAS NOT IDENTIFIED; HOWEVER, SYMBIQ TUBING SETS HAVE A COMMON DEVICE NAME OF 80FRN AND A 510K OF K041550. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH REC'D THAT STATED: "AT THE END OF THE PT'S IV INFUSION, IT WAS DISCOVERED THAT THERE WAS A LEAK AT THE CLAVE CONNECTION OF THE OXALIPLATIN AND THE LEUCOVORIN. SMALL WET SPOT WAS ON PT." UPON FURTHER QUERY, THE FOLLOWING INFORMATION WAS PROVIDED THAT INDICATED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE UNSPECIFIED PRIMARY SYMBIQ TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED VOLUME OF AN UNSPECIFIED MAINTENANCE SOLUTION VIA A SYMBIQ PUMP. AT AN UNSPECIFIED TIME, AN UNSPECIFIED TUBING SET WAS CONNECTED TO THE CLAVE PORT OF THE PRIMARY TUBING SET TO DELIVER UNSPECIFIED CONCENTRATIONS OF OXALIPLATIN AND LEUCOVORIN. IT WAS REPORTED THAT AT THE END OF THE DELIVERIES, LEAKAGE WAS NOTED AT THE CLAVE PORT. AN UNSPECIFIED VOLUME OF THE SOLUTION LEAKED ONTO THE PT. THE PT'S CLOTHING WAS CHANGED. THE TUBING SETS WERE DISCARDED. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO DELAY IN THERAPY CRITICAL FOR THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK FPA HOSPIRA COSTA RICA LTD. NA UNK5H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK