BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA PLS II

    MDR report key: 2963602 · Received November 27, 2012

    Report

    Report Number
    9615050-2012-01413
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 29, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K912928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY MANDATORY MEDWATCH WAS RECEIVED ON (B)(4) 2012. (B)(4). AT THIS TIME THE CUSTOMER WILL NOT BE RETURNING THE DEVICE FOR EVAL. THE DEVICE PASSED TESTING AT THE USER FACILITY AND WAS RETURNED TO CLINICAL SERVICE. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    USER FACILITY MANDATORY MEDWATCH WAS RECEIVED THAT STATED: "A PCA PUMP STARTED TO SMOKE WHILE IN USE IN A PT ROOM. A SPARK WAS SEEN AS WELL AS SMOKE COMING FROM THE BACK OF THE DEVICE." UPON FURTHER QUERY, THE FOLLOWING INFORMATION WAS PROVIDED THAT INDICATED, SPARKS WERE NOTED FROM THE BACK OF THE DEVICE. AT AN UNSPECIFIED TIME, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED MEDICATION, AND DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED LENGTH OF TIME AFTER THE DELIVERY WAS STARTED, THE CUSTOMER CONTACT REPORTED A SUDDEN SPARK AND A POP SOUND WAS HEARD COMING FROM THE DEVICE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PT OR THE NURSE AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING A VISUAL INSPECTION AT THE USER FACILITY, THE CUSTOMER CONTACT REPORTED THAT THE AC POWER CORD WAS CUT WITH EXPOSED BARE WIRES AND CHARRING WAS NOTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA PLS II 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR