BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 0.2 MICRON FILTER SS DEHP FREE

    MDR report key: 10939364 · Received December 3, 2020

    Report

    Report Number
    9616066-2020-20511
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 7, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403234857
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF FILTER LEAKING COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED WITHOUT A FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 20027E LOT NUMBER 20086138 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 12AUG2020. 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 H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT EXT SET 0.2 MICRON FILTER SS DEHP FREE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 20027E BATCH NO: 20086138. IT WAS REPORTED THAT WHILE PRIMING WITH CHEMO, THE FILTER WAS LEAKING ATG. EVENT DESCRIPTION PER EMAIL STATES: RN PRIMED PT'S ATG [CHEMOTHERAPY AGENT] DOSE WITH PRIMARY TUBING AND 0.22 MICRON FILTER. AFTER IT WAS PRIMED, THE FILTER WAS LEAKING ATG. ISSUE WAS REPORTED TO PHARMACY, WHO RE-MADE THE DOSE. FILTER WAS BD SMARTSITE EXTENSION SET 0.2 MICRON LOW PROTEIN BINDING FILTER. DEVICE WAS SAVED WITH PACKAGING FOR UNIT EDUCATOR.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXT SET 0.2 MICRON FILTER SS DEHP FREE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 20027E BATCH NO: 20086138. IT WAS REPORTED THAT WHILE PRIMING WITH CHEMO, THE FILTER WAS LEAKING ATG. EVENT DESCRIPTION PER EMAIL STATES: RN PRIMED PT'S ATG [CHEMOTHERAPY AGENT] DOSE WITH PRIMARY TUBING AND 0.22 MICRON FILTER. AFTER IT WAS PRIMED, THE FILTER WAS LEAKING ATG. ISSUE WAS REPORTED TO PHARMACY, WHO RE-MADE THE DOSE. FILTER WAS BD SMARTSITE EXTENSION SET 0.2 MICRON LOW PROTEIN BINDING FILTER. DEVICE WAS SAVED WITH PACKAGING FOR UNIT EDUCATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408100 EXT SET 0.2 MICRON FILTER SS DEHP FREE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20027E 20086138 50885403234857

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR