BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ DRIVER NEW 8

    MDR report key: 1610257 · Received February 8, 2010

    Report

    Report Number
    2921482-2010-00055
    Event Type
    Injury
    Date Received
    February 8, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 14, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. USER FACILITY VOLUNTARY MEDWATCH WAS RECEIVED ON 02/04/2010.

    Description of Event or Problem · 1

    REPORT 2 OF 2. USER FACILITY VOLUNTARY MEDWATCH RECEIVED THAT STATED "IV PUMP WAS CONNECTED TO PT IN RECOVERY AREA AND FIRE OCCURRED AT THE PLUG." UPON FURTHER QUERY, THE FOLLOWING INFO WAS PROVIDED THAT THE CUSTOMER CONTACT CLARIFIED THAT THERE WAS "BLACK SMOKE BUT NOT A FLAME" AT THE MALE END OF THE POWER CORD WHERE IT ENTERS THE AC OUTLET. A PT NOTED SMOKE COMING FROM THE MALE END OF THE POWER CORD AND NOTIFIED THE NURSE. A FIRE EXTINGUISHER WAS USED ON THE POWER CORD AND AC OUTLET. THE NURSE WAS SENT TO THE EMERGENCY ROOM FOR A "BREATHING TREATMENT" AS A RESULT OF BEING EXPOSED TO THE SMOKE AND CONTENTS OF THE FIRE EXTINGUISHER. THE CUSTOMER CONTACT STATED THE NURSE WAS "TREATED AND RELEASED". THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. DURING TESTING AT THE USER FACILITY, IT WAS NOTED THAT THE MALE END OF THE POWER CORD WAS MELTED AND 2 OF THE PRONGS WERE MISSING. ALTHOUGH REQUESTED, THE CUSTOMER CONTACT DECLINED TO PROVIDE ADDITIONAL INFO, INCLUDING THE NURSE'S AGE, GENDER, DIAGNOSIS, SPECIFIC TREATMENT AND OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ DRIVER NEW 8 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PLUM A+ SOFTWARE MODULE, LIST # 20791| (B) (4)