BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ TRIPLE NEW 8

    MDR report key: 5396661 · Received January 28, 2016

    Report

    Report Number
    9615050-2016-00011
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Date of Event
    January 15, 2016
    Report Date
    January 19, 2016
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY MANDATORY MEDWATCH REPORT WAS RECEIVED ON 01/20/2016. THE REPORT NUMBER IS 180044-199-2016-0001. AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVALUATION. HOWEVER, THREE PICTURES PROVIDED BY THE CUSTOMER WERE REVIEWED, AND IT CAN BE OBSERVED THAT THE AC POWER CORD WAS BURNT AT THE END, WHERE IT CONNECTS TO THE PUMP. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH RECEIVED THAT STATED: "STAFF REPORTED PATIENT WAS RECEIVING IV FLUIDS VIA IV PUMP WHEN THE PATIENT REPORTED TO THE NURSE THAT SPARKS AND A FLAME WAS COMING OUT OF THE BACK OF THE IV PUMP. NURSE TURNED OFF PUMP AND FLAME EXTINGUISHED. GOT A TOWEL AND UNPLUGGED THE IV PUMP. ACCORDING TO NURSE PATIENT STATED THE SPARKS HIT HER ARM BUT CAUSED NO HARM. NO BURN OR REDNESS NOTED TO ARM. IV PUMP WAS REMOVED FROM SERVICE AND TAKEN TO BIOMEDICAL DEPARTMENT. CUT WITH EXPOSED WIRES AND BURNT PLACE NOTED IN CORD WHERE THE CORD IS CONNECTED TO AND ENTERS THE PUMP DEVICE. PUMP WAS PLUGGED INTO AC POWER AT THE TIME OF THE EVENT. NO ISSUE NOTED WITH PRONGS OF CORD. NEW PUMP WAS USED FOR PATIENT IV INFUSION." FURTHER INFORMATION WAS PROVIDED THAT INDICATED THAT THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. ALSO THE DEVICE WAS REPAIRED AT THE USER FACILITY AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54323 PLUM A+ TRIPLE NEW 8 PUMP, INFUSION FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR