BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS LF MIF MAC EXT (C

    MDR report key: 1648644 · Received March 25, 2010

    Report

    Report Number
    9613251-2010-00025
    Event Type
    Malfunction
    Date Received
    March 25, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 26, 2010
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPK
    PMA / PMN Number
    K063239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ARE EXPECTED TO BE RETURNED FOR INVESTIGATION. THEY HAVE NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL: (B) (4).

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LEAKS; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE FEMALE ENDS OF THE TUBING SETS WERE CONNECTED TO UNSPECIFIED PLUMSETS FOR DELIVERY OF EITHER TPN OR REMICADE. THE SECURE LOCK MALE ADAPTERS ON THE DISTAL ENDS OF THE TUBING SETS WERE CONNECTED TO THE PATIENTS' PERIPHERAL VENOUS CATHETERS. IT WAS REPORTED THAT AFTER THE DELIVERIES WERE STARTED, LEAKS WERE NOTED AT THE CONNECTIONS OF THE SECURE LOCK MALE ADAPTERS AND THE PATIENTS' CATHETERS. UNSPECIFIED VOLUMES OF BLOOD LOSS WERE NOTED. THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS, AND NO REPORTED DELAYS IN THERAPIES CRITICAL TO THESE PATIENTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LS LF MIF MAC EXT (C 80FPK FPK HOSPIRA LTD. NA 751054W

    Patients

    Seq Age Sex Outcome Treatment
    1 MAXPLUS PRN IV CATHETERS, MFG BY MAXIMUM| AUTOGARD IV CATHETERS, MFG BY BECTON DICKINSON