BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 10236365 · Received July 6, 2020

    Report

    Report Number
    3012307300-2020-06624
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 1, 2020
    Report Date
    August 26, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586044113
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE SAMPLE WAS RECEIVED FOR EVALUATION AND IT WAS RECEIVED IN USED CONDITION. NO DISCREPANCY WAS DETECTED. THE SAMPLE RETURNED WAS TESTED USING THE HYDROSTATIC VESSEL [CAL ID: 8.0088 DUE DATE: JANUARY 2021] IN ORDER TO DETECT ANY DISCREPANCIES THAT COULD AFFECT THE PRODUCT FUNCTIONALITY AND AN OCCLUSION WAS DETECTED. OTHER ANALYSIS A REVIEW OF THE MANUFACTURING PROCESS FOR EXT SET P/N 21-7605-24; L/N 3983995 WAS CONDUCTED BY QUALITY ENGINEER ON 24/JUN/2020, IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED IN ?DESCRIPTION OF NON-CONFORMANCE? SECTION; ALL PROCEDURES ARE BEING FOLLOWED APPROPRIATELY. THE FOLLOWING OPERATIONS WERE REVIEWED DURING GEMBA: ALL BONDING OPERATIONS WERE REVIEWED TO ENSURE NO EXCESS SOLVENT WAS APPLIED; NO DISCREPANCIES WERE FOUND. LEAK TESTING WERE REVIEWED IN ORDER TO DETECT ANY ANOMALIES; NO DISCREPANCIES WERE DETECTED. PACKAGING OPERATION IN ULMA OPTIMA MACHINE WAS REVIEWED TO ENSURE THAT NO TRAPPED COMPONENTS THAT COULD CAUSE ANY DAMAGE; NO DISCREPANCIES WERE FOUND. VISUAL INSPECTION BEFORE PACKAGING: THIRTY TWO (32) SAMPLES P/N 21-7605-24; L/N 3983995 WERE TAKEN FROM PACKAGING PROCESS IN ORDER TO DETECT ANY DAMAGE OR EXCESS SOLVENT THAT COULD CAUSE OCCLUSION. RESULT: NO DISCREPANCIES WERE FOUND. MITIGATION PRODUCTION PERSONNEL INSPECTS 100% TO ENSURE THAT THE PARTS ARE FREE OF DAMAGED INCLUDING SCRATCHES) OR DISTORTED/WARPED. PRODUCTION PERSONNEL PERFORMS THE LEAK TEST ACCORDING TO THE PQ-016 AND TAKES 4 PARTS AT SHIFT START UP, BEGINNING OF EVERY JOB, A LOT CHANGE INVOLVING BONDED COMPONENTS OR SOLVENT. IN ADDITION, P/N 21-7106 AND 21-7052 MUST ALSO BE LEAK TESTED APPROXIMATELY EVERY 3 HOURS. QUALITY PERSONNEL INSPECTS 15 UNITS EVERY TWO (2) HOURS, PRIOR TO PLACING PRODUCT IN BAG TO ENSURE THAT THE PARTS ARE FREE OF DAMAGE (SCUFFS, PINCH MARKS, ETC.), CRACKS, CRAZING, CUTS OR OTHER WORKMANSHIP DEFECTS THAT CAN AFFECT ASSEMBLY FUNCTION OR APPEARANCE. QUALITY PERSONNEL INSPECTS 15 UNITS EVERY TWO (2) HOURS, PRIOR TO PLACING PRODUCT IN BAG: BONDS SHALL HAVE NO VOIDS THAT ARE MORE THAN 1/2 THE MINIMUM BOND LENGTH. EXCESSIVE SOLVENT ON THE BONDED JOINTS SHALL NOT BE READILY VISIBLE AT A DISTANCE OF 18?. ENSURE TUBES ARE NOT OCCLUDED. FOR TUBE TO TUBE BONDS: BOND ENGAGEMENT TO BE WITHIN 0.250? AND 0.375?. FOR TUBE TO COMPONENTS BONDS: VERIFY TUBING BONDS ARE BOTTOMED OUT OR WITHIN 0.030? OF COMPONENTS STOPS. ROOT CAUSE THE CUSTOMER REPORTED: ?WHEN PERFORMING A PRIMING AT A PRE-USE CHECK, THE CUSTOMER NOTICED THE PUMP (A SOLIS) ISSUED AN OCCLUSION ALARM.? THE MOST PROBABLE ROOT CAUSE IS: EXCESS SOLVENT WAS APPLIED IN THE SOLVENT BONDS. ACTION TAKEN PRODUCTION PERSONNEL WAS TRAINED ON 30-JAN-2020 ON PM-417 REV.104 IN ORDER TO REINFORCE THE SOLVENT APPLICATION. TESTING TO REPLICATE THE FAILURE: FOUR (4) SAMPLES OF OUR INVENTORY FROM P/N 21-7605-24 WERE TAKEN AND THEN EXCESS SOLVENT WAS APPLIED IN THE SOLVENT BONDS, THEN THE SAMPLES WERE TESTED USING THE HYDROSTATIC VESSEL [CAL ID: 8.0088 DUE DATE: JANUARY 2021] IN ORDER TO DETECT OCCLUSIONS. RESULTS: OCCLUSION WERE DETECTED IN ALL SAMPLES.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD EXTENSION SET CAUSED A CADD SOLIS PUMP TO ISSUE AN OCCLUSION ALARM DURING PRIMING AT A PRE-USE CHECK. THE EXTENSION SET WAS REPLACED AND THE PUMP OPERATED NORMALLY. IT WAS SUSPECTED THAT AN OCCLUSION OCCURRED IN THE EXTENSION SET. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697940 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC. 21-7605-24 3883726 10610586044113

    Patients

    Seq Age Sex Outcome Treatment
    1