BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PE DRY/WET CONT REINFUSION LF 6/CS

    MDR report key: 12829231 · Received November 17, 2021

    Report

    Report Number
    3004365956-2021-00308
    Event Type
    Injury
    Date Received
    November 17, 2021
    Date of Event
    February 15, 2021
    Report Date
    November 5, 2021
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAC
    UDI-DI
    14026704631350
    PMA / PMN Number
    K140197
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DHR REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. NO CORRECTIVE ACTION CAN BE ESTABLISHED AT THIS MOMENT SINCE THE PRODUCT SAMPLE IS NOT AVAILABLE FOR EVALUATION. PRODUCT SAMPLE IS NECESSARY TO PERFORM A PROPER INVESTIGATION TO DETERMINATE THE ROOT CAUSE AND THE CORRESPONDING CORRECTIVE ACTIONS. CUSTOMER COMPLAINT CANNOT BE CONFIRMED DUE THE LACK OF DEFECTIVE SAMPLE TO PERFORM A PROPER INVESTIGATION AND DETERMINE THE ROOT CAUSE. AN ATTEMPT TO DUPLICATE THE FAILURE MODE WAS MADE BUT AT THE TIME THERE IS NO INVENTORY OF THE INVOLVED PRODUCT CODE AVAILABLE AT THE FACILITY NEITHER IS BEING MANUFACTURED AT THE TIME.

    Additional Manufacturer Narrative · 0

    QN# (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    MEDWATCH #(B)(4). LARGE PNEUMOTHORAX NOTED ON ROUTINE MORNING CHEST X-RAY. DETERMINED TO BE CAUSED BY AN AIR LEAK IN THE PLEUR-EVAC. PATIENT WAS NOT IN DISTRESS BUT DID HAVE SOME PAIN AND COUGHING. AIR LEAK FIXED AND LUNG RE-EXPANDED.

    Description of Event or Problem · 0

    MEDWATCH # (B)(4). LARGE PNEUMOTHORAX NOTED ON ROUTINE MORNING CHEST X-RAY. DETERMINED TO BE CAUSED BY AN AIR LEAK IN THE PLEUR-EVAC. PATIENT WAS NOT IN DISTRESS BUT DID HAVE SOME PAIN AND COUGHING. AIR LEAK FIXED AND LUNG RE-EXPANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723707 PE DRY/WET CONT REINFUSION LF 6/CS APPARATUS, AUTOTRANSFUSION CAC TELEFLEX MEDICAL IPN028454 14026704631350

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Life Threatening| R