BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AS LVP 20D 2SS CV

    MDR report key: 19005885 · Received March 29, 2024

    Report

    Report Number
    9616066-2024-00496
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    February 14, 2024
    Report Date
    May 8, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K221327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. ADDITIONAL LOT NUMBERS PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER (B)(4): 23125020 MFG 2023-12-01 EXP 2026-12-01; 23125054 MFG 2023-12-01 EXP 2026-12-01; 23125204 MFG 2023-12-07 EXP 2026-12-07.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT TUBING KINKED JUST BELOW THE DRIP CHAMBER. ONE USED SAMPLE MODEL 2420-0007 LOT 23125214 AND EIGHT UNOPENED SAMPLES MODEL 2420-0007 (4 LOT 23125020, 3 LOT 23125054, 1 LOT 23125204) WAS RETURNED FOR INVESTIGATION. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. THE ONE UNUSED SET ALONG WITH TWO LOT 23125020, THREE LOT 23125054 AND ONE LOT 23125204 SHOWED SIGNS OF A KINK BELOW THE DRIP CHAMBER. ALL SET WAS PRIMED WITH WATER WHICH INDICATES THAT THE KINKS DID NOT COMPLETELY OCCLUDE THE TUBING. HOWEVER, THE TUBING IS MORE SUSCEPTIBLE TO OCCLUDE DUE TO THE KINK. A QUALITY NOTIFICATION WAS SENT TO THE MANUFACTURER. FROM THE MANUFACTURER'S INVESTIGATION, THE POSSIBLE ROOT CAUSE FOR KINKED TUBING COULD BE RELATED TO PRODUCT INCORRECTLY ACCOMMODATED IN THE POUCH DUE TO NOT USE OF THE FUNNEL OR INCORRECT USE BY THE ASSEMBLER. A QUALITY ALERT WAS PERFORMED ON (B)(6) 2024 BY THE QUALITY ENGINEER ¿ POST MARKET SUPPORT AND COMMUNICATED BY PRODUCTION SUPERVISOR TO INVOLVED PERSONNEL TO INFORM THIS FAILURE MODE AND REINFORCE FOLLOW THE OPERATIONS DESCRIBED IN THE SWS, THE CORRECT COILING OF THE SET AND CORRECT USE OF THE FUNNEL TO AVOID KINKED TUBING IN THE PRODUCT. A DHR WAS PERFORMED ON LOTS 23125020, 23125054, 23125204 AND 23125214. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. H3 OTHER TEXT : SEE H10 BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD AS LVP 20D 2SS CV TUBING KINKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: TUBING KINKED JUST BELOW THE FILL CHAMBER AT THE TOP. WILL NOT UNKINK. NOTE: ALARIS STANDARD TUBING BEING KINKED. NIGHTSHIFT HAD A SET OF TUBING THAT WAS KINKED FROM PACKAGING, WHICH CAUSED ALARMS ON THE PUMP. THEY PULLED SEVERAL OTHER TUBING THAT APPEARED KINKED IN THE PACKAGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2389773 BD AS LVP 20D 2SS CV SET, ADMINISTRATION, INTRAVASCULAR FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23125214 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown