BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ LVP 20D 2SS CV

    MDR report key: 15749597 · Received November 7, 2022

    Report

    Report Number
    9616066-2022-01687
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    September 23, 2022
    Report Date
    December 15, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: LOT WAS REPORTED; HOWEVER, THIS IS NOT A LOT # 220658 MANUFACTURED FOR THE REPORTED CATALOG #. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 13-OCT-2022. MEDWATCH REPORT # 0501500000-2022-8005. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. A.2. DATE OF BIRTH: PATIENT¿S BIRTHDAY WAS NOT PROVIDED, (B)(6)1951 WAS USED BASED ON AGE OF PATIENT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 2420-0007. D4: MEDICAL DEVICE EXPIRATION DATE: 14-JUN-2025. H4: DEVICE MANUFACTURE DATE: 13-JUN-2022. D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 18-OCT-2022. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THE TUBING SEPARATED DURING PRIMING, AND RETURNED THE SAMPLE. THE SAMPLE SEPARATED AT THE LOWER FITMENT SOLVENT CONNECTION, AND THE COMPLAINT IS VERIFIED. THERE WAS A MINIMAL AMOUNT OF SOLVENT APPLIED, AND WAS QUITE SHALLOW ON THE TUBING. THE ROOT CAUSE IS TRACED TO THE ASSEMBLY PROCESS APPLYING THE SOLVENT. THIS HAS BEEN ADDRESSED UNDER TWO SEPARATE QUALITY NOTIFICATIONS SINCE THE TIME THIS LOT WAS MADE: ONE FOR THE CORRECT ASSEMBLY OF TUBING/LOWER FITMENT; SECOND FOR THE CORRECT METHOD OF ADDING SOLVENT TO THE TUBE/COMPONENT. DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 22065892 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON (B)(6) 2022. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD ALARIS¿ LVP 20D 2SS CV CAME APART WHEN PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV TUBING CAME APART WHEN PRIMING THE LINE WITH SALINE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE BD ALARIS¿ LVP 20D 2SS CV CAME APART WHEN PRIMING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV TUBING CAME APART WHEN PRIMING THE LINE WITH SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2334667 BD ALARIS¿ LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22065892 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male