BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 14204674 · Received April 26, 2022

    Report

    Report Number
    9681834-2022-00080
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 7, 2022
    Report Date
    April 26, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION - TECHNOLOGIST. PMA/510(K)- K071494, K130520. THE ACTUAL DEVICE HAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT /LOT NUMBER COMBINATION CONFIRMED THAT THERE WAS NO ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR COMPLAINTS WITH THE INVOLVED PRODUCT /LOT NUMBER COMBINATION. (B)(4).

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION FINDINGS - CODE 3221 IS BASED UPON THE EVALUATION OF USER FACILITY INFORMATION AND NO SAMPLE RETURNED; CODE 3252 IS BASED UPON THE PICTURE PROVIDED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE AN UPDATE TO SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. A REVIEW OF THE PROVIDED PICTURE CONFIRMED THAT THE PURGE LINE HAD BEEN FRACTURED. IT WAS PRESUMED THAT THE PRODUCT MIGHT HAVE BEEN EXPOSED TO A SHOCK FORCE DURING TRANSPORTATION OR HANDLING, WHICH RESULTED IN A CRACK IN THE TUBE LEADING TO LEAK. HOWEVER, SINCE THE STATE OF THE ACTUAL SAMPLE COULD NOT BE CONFIRMED, THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PART CAPS ARE OFF. DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR. IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PURGE LINE ON THE CAPIOX FX25 INVOLVED BROKE OFF AFTER UNPACKING. THE PATIENT WAS NOT HARMED. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE EVENT OCCURRED PRE-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590771 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 210816 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male