BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10242990 · Received July 7, 2020

    Report

    Report Number
    3012307300-2020-06694
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Report Date
    August 17, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: RETURNED DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. NO EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING THE EVALUATION OF THE DEVICE, ACCURACY TESTING WAS FOUND TO ALL BE WITHIN SPECIFICATIONS. FLUID INGRESSION'S WERE FOUND IN THE CHASSIS BASE OF THE EXPULSOR. THE DOWNSTREAM AND UPSTREAM OCCLUSION ALARMS WERE ALSO FOUND TO BE BENT AND CRACKED AS WELL AS THE ADMINISTRATION CASSETTE SLOT IN THE CHASSIS. HOWEVER, NO FAULT WAS FOUND WITH THE PUMP WORKING. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 0

    ORACLE RO 1072006: FAIL ACCURACY - 8.6 %. ADDITIONAL INFORMATION RECEIVED ON 26-JUN-2020: NO PATIENT INVOLVEMENT. EVENT DETAILS UPDATED.

    Additional Manufacturer Narrative · 1

    RETURNED DEVICE WAS RECEIVED IN POOR PHYSICAL CONDITION. THE TOP CASE WAS CRACKED AT THE CORNERS. IT WAS MISSING THE EAR CLIP AND OPTOCOUPLER. THE PUMP ALSO HAD A BROKEN RIGHT PLUNGER CASE. EVIDENCE OF REPORTED PROBLEM IN EVENT LOG WAS FOUND. DURING EVALUATION OF THE DEVICE, ANALYSTS WERE UNABLE TO PERFORM OCCLUSION TESTS AS THE EAR CLIP AND PLUNGER LEVER ARE BOTH MISSING. THERE WAS A COMBINATION OF DEBRIS ON THE U29 SENSOR AND NORMAL WEAR OF THE MOTOR MOTOR ASSEMBLY FOUND. THE CAUSE WAS FOUND TO BE THESE DAMAGED COMPONENTS. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL MEDFUSION SYRINGE PUMP HAD A MOTOR ISSUE. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705181 CADD PUMP, INFUSION FRN ST PAUL 21-6400-51 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1