BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 9983208 · Received April 21, 2020

    Report

    Report Number
    3012307300-2020-03366
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Report Date
    July 1, 2020
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOUR CADD ADMINISTRATION SETS FROM P/N 21-7322-24 ONE FROM L/N 3765250, ONE FROM L/N 3931737 AND TWO FROM L/N 3886096 WERE RECEIVED IN USED CONDITIONS INSIDE A PLASTIC BAG WITH THEIR ORIGINAL PACKAGING OPEN THE SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION. ALL THE SAMPLES WERE RECEIVED NUMBERED FROM 1 TO 4; SAMPLE #1 CORRESPOND TO L/N 3765250, SAMPLE #2 CORRESPOND TO L/N 3931737 AND SAMPLES #3 AND #4 CORRESPOND TO L/N 3886096. A KINK WAS DETECTED ON THE PUMP TUBE OF THE FOUR SAMPLES CAUSED BY THE FFP SYSTEM SINCE THAT THEY WERE RETURNED WITHOUT THE BLUE CLIP, THE ARCH HEIGHT PUMP TUBE WAS TOO LOW ALMOST FLAT; ALSO SAMPLE #2 AND #4 HAD THE PUMP TUBE MISALIGNED. THE SAMPLES WERE SET FOR ACCURACY TESTING USING A PUMP SOLIS VIP AND A BALANCE METTLER TOLEDO. THE FUNCTIONAL TEST COULD NOT BE PERFORMED ON SAMPLES 1, 2 AND 3 DUE TO THE FACT THAT THE KINK DETECTED DID NOT ALLOW THE FLUID TO PASS; ONLY SAMPLE 4 COULD BE PRIMED AND SUBMITTED TO THE TEST. NO DISCREPANCIES WERE DETECTED; SAMPLE PASSED THE TEST. RELEVANT DOCUMENTS WHICH WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES. SINCE THE REPORTED ISSUE IS A KNOWN PROBLEM, BASED ON VISUAL INSPECTION OF THE SAMPLES, THE MOST PROBABLE CAUSE IS THAT THE PUMP TUBE ARCH HEIGHT IS TOO LOW. THERE WAS NO FAULT FOUND WITH THE RETURNED ADMINISTRATION SET.

    Additional Manufacturer Narrative · 0

    H2: SEE A1, B5, D4, H4 AND H6(PATIENT CODE).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EVENT OCCURRED DURING ANNUAL TESTING. IT WAS SPECIFIED THAT THE CADD ADMINISTRATION SET UNDER-DELIVERED AND THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD DISPOSABLE SET DISPLAYED VOLUME ACCURACY ISSUES. DIFFERENT SETS WERE TRIED, PRODUCING DIFFERENCE RESULTS. THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444557 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASC FPA 3886096

    Patients

    Seq Age Sex Outcome Treatment
    1