BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+ PLATINUM

    MDR report key: 4210821 · Received August 1, 2014

    Report

    Report Number
    9615050-2014-04655
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 11, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND THE DEVICE WAS RECEIVED WITH A CRACKED FRONT AND REAR ENCLOSURE. AT POWER ON, THE DEVICE ENTERED A REBOOTING CYCLE AND ALARMED AS IT POWERED ON AND OFF WITH A BLANK DISPLAY. THE DEVICE WAS OPENED AND A VISUAL INSPECTION FOUND THAT THE FLAT CABLE BETWEEN THE CPU AND LCD WAS MISSING, THE FLAT CABLE BETWEEN THE CPU AND THE MECHANISM WAS DAMAGED, THE PIEZO ASSEMBLY WAS THE PRE-REMEDIATION PHASE 1 TYPE AND THE PIEZO ASSEMBLY CONDUCTOR WAS PINCHED AND PARTIALLY CUT. AFTER REPLACING THE MISSING AND DAMAGED COMPONENTS, THE DEVICE WAS POWERED ON AND PASSED THE SELF-TEST SUCCESSFULLY AND WITHOUT ERROR. THE ALARM LOUDNESS TEST WAS PERFORMED AND COMPLETED WITHOUT ERROR. THE DEVICE PASSED ALL PVT TESTING WITHOUT ERROR AND WITHIN SPECIFICATIONS. THE RESULTS OF THE PVT OCCLUSION TESTS WERE AS FOLLOWS: THE DEVICE OCCLUDED AT 6.3 PSI [SPEC: 6.0 PSI +3.0 PSI] FOR THE 6 PSI LIMIT AND OCCLUDED AT 10.2 PSI [SPEC: 10.0 PSI + 3.0 PSI] FOR THE 10 PSI LIMIT. THE MEASURE VOLUME ACCURACY WAS 19.80 ML [SPEC: 20.0 ML + 1.0 ML]. A RUN-IN TEST WAS PERFORMED ON BOTH LINES AT RATE OF 150 ML/HR FOR SIX HOURS AND WAS COMPLETED SUCCESSFULLY WITHOUT ERROR. THE COMPLAINT OF DEVICE CYCLING ON AND OFF AND ALARMING WITH BLANK DISPLAY WAS CONFIRMED DURING PRODUCT COMPLAINT INVESTIGATION TESTING AND IS ATTRIBUTABLE TO THE DEVICE. THE PROBABLE CAUSE OF THE COMPLAINT IS A DEFECTIVE CPU PWA ASSEMBLY, A DAMAGED CPU PWA TO MECHANISM CABLE AND A MISSING CPU PWA TO LCD CABLE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, IT WAS NOTED THE DEVICE ALARMED E301 (AUDIO ALARM FAILURE), CYCLING POWER AND NO DISPLAY. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS OR DELAYS IN CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452118 PLM A+ PLATINUM 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SN # (B)(4)| PLUM A+ SOFTWARE MODULE, LIST # 12097,