BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 9325293 · Received November 14, 2019

    Report

    Report Number
    3012307300-2019-06473
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    September 1, 2019
    Report Date
    January 20, 2023
    Manufacturer
    SMITHS MEDICAL ASD,INC
    Product Code
    MRZ
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE SAMPLE WAS IN USED CONDITIONS WITHOUT ITS ORIGINAL PACKAGING. NO VISUAL DISCREPANCIES WERE FOUND. THE SAMPLE WAS CONNECTED TO A PUMP AND AN ACCURACY TEST WAS PERFORMED. THE DEVICE PASSED THE ACCURACY TEST. A REVIEW OF THE MANUFACTURING PROCESS FOR WAS CONDUCTED BY QUALITY INTERN IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT. NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS NO ISSUE WAS FOUND WITH THE DEVICE DURING THE INVESTIGATION. THE QUALITY INTERN NOTIFIED THE PRODUCTION PERSONNEL OF THE FAILURE MODE REPORTED BY THE CUSTOMER AS A PREVENTATIVE MEASURE.

    Additional Manufacturer Narrative · 0

    H3: ONE CADD CASSETTE RESERVOIRS FROM P/N 21-7302-24 L/N 3776385 WAS RECEIVED IN USED CONDITIONS WITHOUT ITS ORIGINAL PACKAGING INSIDE IN A PLASTIC BAG. THE SAMPLE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12" TO 24" AND NORMAL CONDITIONS OF ILLUMINATION. THE CASSETTE WAS IN GOOD CONDITION WITH A TUBE NOT MANUFACTURED BY SMITHS MEDICAL OF TIJUANA. THE SAMPLE WAS CONNECTED TO THE CADD LEGACY PLUS AND A BALANCE METTLER TO LOOK FOR UNUSUAL FUNCTION. THE SAMPLE PASSED ACCURACY TESTS SUCCESSFULLY. RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES. THE REPORTED UNDER INFUSION ISSUE WAS UNABLE TO BE CONFIRMED. THERE WAS NO FAULT FOUND WITH THE RETURNED CASSETTE.

    Description of Event or Problem · 1

    REPORTED A SMITHS MEDICAL CADD CASSETTE RESERVOIR WAS UNDER INFUSING. REPORTED INFUSION TO RUN OVER TWENTY FOUR HOURS WITH A RATE OF 3.5ML/HR. THE REPORTED AMOUNT OF VOLUME TO INFUSE IS 84 MILLILITERS WITH 16 MILLILITERS REMAINING IN THE RESERVOIR. HOWEVER, HAD NOTICED WITH SEVERAL CASES MORE THAN 16 MILLILITERS HAVE REMAINED AND AS HIGH AS 30 MILLILITERS HAVE REMAINED IN RESERVOIR. REPORTED TO DR. (B)(6), THE ATTENDING PHYSICIAN, ON (B)(6), THE DISCREPANCY. IT IS RECOGNIZED THAT IT IS ABNORMAL BECAUSE IT EXCEEDS THE RANGE OF CALIBRATION . NO SERIOUS INJURY REPORTED. SYMPTOMS OF HEADACHE OR DIARRHEA MAY ERUPT, ACCORDING TO COMPLAINT BUT NO ADVERSE SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118233 CADD CASSETTE RESERVOIR ACCESSORIES, PUMP, INFUSION MRZ SMITHS MEDICAL ASD,INC 21-7302-24 3776385 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female