BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIR

    MDR report key: 10178828 · Received June 22, 2020

    Report

    Report Number
    3012307300-2020-06113
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    May 1, 2020
    Report Date
    August 25, 2020
    Manufacturer
    ST PAUL
    Product Code
    FPA
    UDI-DI
    10610586027239
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONCE PICTURE OF THE PRODUCT WAS RECEIVED AND REVIEWED BY THE INVESTIGATION TEAM. ADDITIONALLY, THE PRODUCT WAS RETURNED. IN ADDITION, A REVIEW OF MANUFACTURING PRACTICES WAS PERFORMED TO SEE IF THERE WAS ANY PRACTICES THAT COULD HAVE CAUSED THE EVENT. RESULTS: THE PICTURE SHOW THE TOP VIEW OF A CASSETTE PRODUCT, NO DISCREPANCIES WERE DETECTED. SAMPLES RECEIVED BY SHM: THE SAMPLE CONSIST IN ONE (1) CASSETTE PRODUCT OF P/N 21-7302-24 L/N UNKNOWN, THE SAMPLE WAS RECEIVED IN USED CONDITIONS WITHOUT ITS ORIGINAL PACKAGING INSIDE IN A PLASTIC BAG. VISUAL INSPECTION: THE SAMPLE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12? TO 24? AND NORMAL CONDITIONS OF ILLUMINATION. RESULTS: NO DISCREPANCIES WERE DETECTED. FUNCTIONAL TEST: THE SAMPLE WAS CONNECTED TO THE CADD LEGACY PLUS [CAL. ID: 1.0130; DUE DATE: NOVEMBER 2020] TO LOOK FOR UNUSUAL FUNCTIONS. RESULTS: THE SAMPLE WAS FULLY PRIMING AND CONNECTED WITHOUT DIFFICULT, THE PUMP WAS SET RUNNING AND ANY ALARM WAS ACTIVATED. THE FOLLOWING ARE RELEVANT DOCUMENTS WHICH WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES: PM-1008 REV. 112 CASSETTE BONDING. PM-1009 REV. 109 CASSETTE BAG LOADING. PM-1010 REV. 119 CASSETTE TURNTABLE, UV ADHESIVE APPLICATION AND CURING. PM-322 REV. 106 ACCURACY TEST PROCEDURE. QP 67-2265 REV. 116 DELTEC CASSETTE (INTERNATIONAL AND ENTERAL). A REVIEW OF THE MANUFACTURING PROCESS FOR P/N 21-7302-24 L/N 4013376 WAS CONDUCTED BY QUALITY INTERN ON 23/JUL/2019, IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED IN ?COMPLAINT DESCRIPTION? SECTION. THE FOLLOWING OPERATIONS WERE REVIEWED, IN ORDER TO VERIFY THAT THE OPERATIONS WERE PROPERLY PERFORMED, ALSO RECORDS WERE REVIEWED, IN ORDER TO ENSURE THAT COMPLIED WITH GMP?S REQUIREMENTS AND SHM PROCEDURES: ACCURACY TEST WAS REVIEWED IN THREE (3) UNITS, IN ORDER TO VERIFY THAT NO ALARMS WERE ACTIVATED; NO DISCREPANCIES WERE FOUND. A REVIEW OF THE PRODUCTION FLOOR WAS CONDUCTED, A SAMPLE OF 32 UNITS WERE TAKEN IN ORDER TO VERIFY FOR OCCLUSIONS, KINKED TUBING AND THAT THE BAGS WERE CORRECTLY PLACED; NO DISCREPANCIES WERE DETECTED. PRODUCTION PERFORMS A 100% IN PROCESS INSPECTION, IN ORDER TO VERIFY FOR OCCLUSIONS, KINKED TUBING VERIFY THAT THE BAG IS PROPERLY PLACED AND VERIFIES THAT THE HEIGHT OF THE ARCH OF THE PUMP TUBE IS WITHIN SPECIFICATION. PRODUCTION PERFORMS AN ACCURACY TEST; TAKES A SAMPLE OF (3) PARTS AT SHIFT START-UP, BEGINNING OF EVERY JOB; AT LEAST EVERY (5) HOURS. QUALITY TAKES A SAMPLE OF 15 UNITS AT AN INTERVAL OF TWO (2) HOURS +/- 30 MINUTES, PRIOR TO PLACING PRODUCT IN BAG, IN ORDER TO VERIFY FOR OCCLUSIONS, KINKED TUBING AND VERIFY THAT THE BAG IS PROPERLY PLACED AND VERIFIES THAT THE HEIGHT OF THE ARCH OF THE PUMP TUBE IS WITHIN SPECIFICATION. QUALITY VERIFIES THAT THE ACCURACY TEST IS BEEN CORRECTLY PERFORMED. THE CUSTOMER REPORTED: ?SMJ#CFFJ103. DURING THE USE OF THE PRODUCT, THE PRODUCT (A MEDICATION CASSETTE) ISSUED AN ALARM AND STOPPED. THE CUSTOMER THEN REPLACED THE PRODUCT WITH ANOTHER ONE. AFTER THAT, NO ALARM WAS ISSUED. NO PATIENT INJURY?. ROOT CAUSE CANNOT BE DETERMINED SINCE THE COMPLAINT WAS NOT CONFIRMED DUE TO THE FACT THE SAMPLE WAS TESTED AND THE ALARM WAS NOT ACTIVATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL CONTACT: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE, A SMITHS MEDICAL CADD CASSETTE RESERVOIR ISSUED AN ALARM. SUBSEQUENTLY, THE CASSETTE WAS REPLACED, AND NO ALARM WAS ISSUED AFTER. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641966 CADD CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR FPA ST PAUL 21-7302-24 10610586027239

    Patients

    Seq Age Sex Outcome Treatment
    1