BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, INTRAVASCULAR, PRODUCT CODE: FPA

    MDR report key: 9989112 · Received April 22, 2020

    Report

    Report Number
    3012307300-2020-03294
    Event Type
    Malfunction
    Date Received
    April 22, 2020
    Report Date
    June 29, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    UDI-DI
    10610586029646
    PMA / PMN Number
    K040636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H2: ADDITIONAL INFORMATION: SEE D10 H3: 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING AN ANNUAL TESTING OF A SMITHS MEDICAL CADD PUMP THE INTRAVASCULAR ADMINISTRATION SET, UNDER-DELIVERED. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452491 SET, ADMINISTRATION, INTRAVASCULAR, PRODUCT CODE: FPA CADD ADMINISTRATION SETS FPA SMITHS MEDICAL ASD, INC. 21-7322-24 3931737 10610586029646

    Patients

    Seq Age Sex Outcome Treatment
    1