BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N CR

    MDR report key: 6348064 · Received February 21, 2017

    Report

    Report Number
    9615050-2017-00029
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 14, 2017
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION DID NOT FIND ANY MELTED OR BURNED PART UPON VISUAL INSPECTION. THE MODULE COVER AND REAR CASE INSERT WERE BROKEN AND SPILLAGE WAS FOUND ON THE DRIVER PWA (PRINTED WIRING ASSEMBLY), PRESSURE DETECTOR AND PLUNGER MOTOR. THE BROKEN PARTS WERE REPLACED AND THE DEVICE PASSED THE SELF-TEST. THE PROBABLE CAUSE IDENTIFIED FOR THE DAMAGED MODULE COVER AND REAR CASE INSERT WAS PHYSICAL DAMAGE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BOTTOM END OF THE PUMP MODULE IS DENTED IN/MELTED. THE CUSTOMER DOES NOT KNOW IF THE PUMP WAS DROPPED, IF THE CORNER OF THE PUMP HIT SOMETHING, OR IF THE PUMP WAS IN A HEATED ENVIRONMENT. THERE WERE NO REPORTS OF ADVERSE PATIENT EVENTS, MEDICAL INTERVENTIONS OR DELAYS IN CRITICAL THERAPIES, WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE BOTTOM END OF THE PUMP MODULE IS DENTED IN/MELTED. THE CUSTOMER DOES NOT KNOW IF THE PUMP WAS DROPPED, IF THE CORNER OF THE PUMP HIT SOMETHING, OR IF THE PUMP WAS IN A HEATED ENVIRONMENT. THERE WERE NO REPORTS OF ADVERSE PATIENT EVENTS, MEDICAL INTERVENTIONS OR DELAYS IN CRITICAL THERAPIES, WHILE THE DEVICE WAS IN CLINICAL USE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128158 PLMA DVC V11.51 1 N CR PUMP INFUSION FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1