BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 12330950 · Received August 17, 2021

    Report

    Report Number
    3012307300-2021-08505
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    June 14, 2021
    Report Date
    April 20, 2023
    Manufacturer
    NULL
    Product Code
    FPA
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION: H6, H10: DEVICE EVALUATION: TWO SMITHS MEDICAL CADD CASSETTE RESERVOIRS WERE RETURNED FOR ANALYSIS IN A USED CONDITION. THE SAMPLES WERE TESTED TO MEASURE THE HEIGHT OF THE PUMP TUBE ARCH AND DETERMINE IF IS UNDER OR OUT OF SPECIFICATION. IT WAS NOTED THAT THE PUMP TUBE HEIGHT OF SAMPLES WAS OUT OF SPEC HOWEVER DUE SAMPLES WERE RECEIVED IN USED CONDITIONS IS IT POSSIBLE THE PUMP TUBE HEIGHT COULD BE MODIFIED DURING THE USE OR TRANSPORTATION. THE SAMPLES RECEIVED WERE CONNECTED TO THE CADD LEGACY PLUS AND TO BALANCE METTLER TOLEDO TO LOOK FOR UNUSUAL FUNCTION, SAMPLES WERE FULLY PRIMING AND CONNECTED WITHOUT DIFFICULTY, THE PUMP WAS SET RUNNING AND THE ALARM WAS NOT ACTIVATED. THE CASSETTES PASSED THE TESTS. BASED ON THE EVIDENCE, THE COMPLAINT WAS NOT CONFIRMED, AND NO FAULT WAS FOUND.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION: H6 THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4)., CORRECTED DATA: H1: CORRECTION PRODUCT PROBLEM G5: K040636.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL CADD CASSETTE RESERVOIR FOR HIGH DOSE OF DILAUDID, A NO DISPOSABLE ALARM WAS NOTED. IT WAS NOTED THAT THE PATIENT WAS WITHOUT PAIN MEDICATION FOR SEVERAL HOURS UNTIL A NEW CASSETTE WAS COMPOUNDED, DELIVERED, CONNECTED AND THERAPY WAS RESUMED. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229257 CADD SET, ADMINISTRATION, INTRAVASCULAR FPA 4096352

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female