BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 9323450 · Received November 14, 2019

    Report

    Report Number
    3012307300-2019-06084
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 15, 2019
    Report Date
    February 21, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION AND TESTING DONE BY THIRD PARTY. THE COMPLAINT COULD NOT BE VERIFIED FOR LEAK. THE PRODUCT WAS NOT RETURNED BUT TESTING AND INSPECTION WAS DONE ON CONTROL ANALYSIS AND MITIGATION. A PICTURE WAS RECEIVED AND VARIOUS POINTS ARE MARKED AND IDENTIFIED WITH LETTERS A ALONG TO BOTH PRODUCTS. NO LEAKS NOR DROPS IT CAN BE SEE FLEEING FROM POINT B, WHICH IT IS THE AFFECTED SECTION ACCORDING OF THE COMPLAINT DESCRIPTION. REVIEWING MANUFACTOR PROCESS FOR P/N 21-7302-24 L/N 3894451 WAS CONDUCTED BY QUALITY INTERN ON 11-NOV-2019 AND COMPLAINT DECRIPTION COULD NOT BE VERIFIED THERE. MITIGAION REVEALED PRODUCT PERFORMED 100% IN PROCESS LEAK TEST. ROOT CAUSE CAN NOT BE ESTABLISHED AS NO PRODUCT WAS RETURNED. DHR REVEIVED COMPLAINT AND THERE SUMMARY AS FOLLOWS. PART NUMBER: 21-7302-24 LOT NUMBER: 3761268 MANUFACTURING DATE: JANUARY, 2019 QUANTITY RELEASED: (B)(4) UNITS. ANY RELEVANT DMRS, IDRS, DAS: THERE WERE NO RELEVANT IDR'S, DMR'S OR DA'S FOR THIS LOT ANY RELEVANT REWORK: NONE PER REVIEW OF THE DHR WAS SCRAP/REJECTS ABOVE TYPICAL? NONE PER REVIEW OF THE DHR COMPONENT LOT NUMBER AND QUANTITY ISSUED: THERE WERE NO RELEVANT IDR'S, DMR'S OR DA'S FOR THIS LOT COMPONENT HISTORY: THERE WERE NO RELEVANT FINDINGS DETECTED IN THE DHR. SUMMARY OF DHR REVIEW: THERE WERE NO RELEVANT IDR'S, DMR'S OR DA'S FOR THIS LOT UPDATED FIELDS ON FOLLOW UP A 1 B 1 B 4 B 5 B 7 G 7 H 1 H 2 H 3 H 6 H 10.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND WILL BE GENERATED IN H 10. ADDITIONAL INFORMAITON RECEIVED 15-JAN-2020: CUSTOMER RESPONSE.

    Additional Manufacturer Narrative · 1

    OCCUPATION: QUALITY ASSOCIATE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD CASSETTE RESERVOIR HAD A SPLIT LINE. A CADD MEDICATION CASSETTE, 100ML (FLOWSTOP) DEVICE WAS CONNECTED TO THE PATIENT ON (B)(6) 2019, THE PATIENT REPORTED BACK TO THE HOSPITAL WITH A SPILT BETWEEN THE CADD CASSETTE AND THE FIRST CONNECTION. THIS RESULTED IN A CYTOTOXIC SPILL CONTAMINATING THE PATIENT'S CLOTHING AND BEDDING. THE PUMP READ AS "44.3ML TO RUN OVER 10 HOURS" BUT THE CASSETTE WAS ALMOST EMPTY. THERE WERE NO REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119599 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7302-24 3761268 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1