BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER

    MDR report key: 15804096 · Received November 16, 2022

    Report

    Report Number
    9681834-2022-00234
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 28, 2022
    Report Date
    November 16, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K): K130280. THE ACTUAL SAMPLE WAS DISCARDED BY THE INVOLVED FACILITY; THEREFORE, THE ACTUAL DEVICE WILL NOT BE RETURNED FOR EVALUATION. THE PROVIDED IMAGE WAS CONFIRMED. IT WAS FOUND THAT THE FEMALE LUER ON THE RED COCK SIDE OF THE SAMPLING SYSTEM WAS DAMAGED AT THE BASE. THE CONDITION OF THE DAMAGED SURFACE COULD NOT BE CONFIRMED FROM THE IMAGE. REVIEW OF THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD OF THE ACTUAL PRODUCT CONFIRMED THAT THERE WAS NOT ANY ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. BASED ON THE INVESTIGATION RESULT, NO ANOMALY WAS FOUND IN THE MANUFACTURING RECORDS. SINCE THE CONDITION OF THE DAMAGED SURFACE OF ACTUAL PRODUCT COULD NOT BE CONFIRMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT IFU REFERENCE: "DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. (METHOD OF OPERATION, A. SET-UP, 1, CAUTION)". " IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE. (A. SET-UP, CAUTION)". (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHEN THE CAIPOX DEVICE WAS CONNECTED, THE SAMPLING PORT WAS FOUND TO BE BROKEN. THE EVENT OCCURRED PRE-TREATMENT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FINAL PATIENT IMPACT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352695 CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 211220 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown