BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10348475 · Received July 30, 2020

    Report

    Report Number
    3012307300-2020-07718
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Report Date
    October 20, 2020
    Manufacturer
    ST PAUL
    Product Code
    MEA
    PMA / PMN Number
    K170982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: , CORRECTED DATA: CORRECTION G 4 AWARE DATE FOR FOLLOW UP 07/10/2020.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: , CORRECTED DATA: CORRECTION G 4 AWARE DATE FOR FOLLOW UP (B)(6) 2020

    Additional Manufacturer Narrative · 0

    H3: ONE CADD SOLIS HPCA PUMP WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NO DAMAGES OR CRACKS COULD BE FOUND. THE CUSTOMER'S REPORTED PROBLEM REGARDING DELIVERY ACCURACY WAS ABLE TO BE DUPLICATED. THREE SEPARATE DELIVERY ACCURACY TESTS WERE PERFORMED; AT LEAST ONE TEST WAS OUTSIDE THE PUMP'S DELIVERY ACCURACY MANUFACTURING SPECIFICATIONS. THE EXPULSOR WILL BE REPLACED TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS SENT ON JULY 10TH, 2020. REVEALING ACCURACY FAILED DURING TESTING AND NOT PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    CORRECTIVE INFORMATION BEING SUBMITTED ON G 4 AWARE DATE.

    Description of Event or Problem · 0

    CORRECTIVE INFORMATION BEING SUBMITTED ON G 4 AWARE DATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT CADD SOLIS HPCA PUMP FAILED ACCURACY TESTING BY 21.2ML. THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808336 CADD PUMP, INFUSION MEA ST PAUL 21-2111-0100-51

    Patients

    Seq Age Sex Outcome Treatment
    1