BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLMA DVC V11.51 1 N CR

    MDR report key: 5493419 · Received March 10, 2016

    Report

    Report Number
    9615050-2016-00037
    Event Type
    Malfunction
    Date Received
    March 10, 2016
    Date of Event
    March 3, 2016
    Report Date
    March 4, 2016
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION FOUND DURING VISUAL INSPECTION THAT THE DISTAL PRESSURE PIN ON THE PRESSURE DETECTOR ASSEMBLY WAS BROKEN. THE DEVICE DID NOT PASS THE DISTAL OCCLUSION TEST; HOWEVER THE DEVICE AUDIBLY ALARMED FOR A DISTAL OCCLUSION DURING THE 6 PSI SETPOINT AT 25.63 PSI. THE PROBABLE CAUSE WAS DUE TO PHYSICAL DAMAGE TO THE PRESSURE DETECTOR ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT PASS THE DISTAL OCCLUSION TEST BY CONTINUING TO INFUSE PAST 25 PSI AT THE 6 PSI SETPOINT. IT WAS FURTHER REPORTED THAT THE CUSTOMER CONFIRMED THE DEVICE DID NOT DETECT A DISTAL OCCLUSION. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS 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 CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT PASS THE DISTAL OCCLUSION TEST BY CONTINUING TO INFUSE PAST 25 PSI AT THE 6 PSI SETPOINT. IT WAS FURTHER REPORTED THAT THE CUSTOMER CONFIRMED THE DEVICE DID NOT DETECT A DISTAL OCCLUSION. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS 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
    147745 PLMA DVC V11.51 1 N CR PUMP, INFUSION FRN HOSPIRA COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1