BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 14163447 · Received April 20, 2022

    Report

    Report Number
    9681834-2022-00065
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 20, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 - CHIEF PERFUSIONIST. 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. REVIEW OF THE PROVIDED IMAGE OF THE ACTUAL PRODUCT CONFIRMED THE LEAK FROM THE PURGE. A REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT/LOT# COMBINATION CONFIRMED THERE WAS NO INDICATION OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION FROM OTHER FACILITIES. SINCE NO ANOMALY WAS CONFIRMED IN THE MANUFACTURING RELATED RECORDS, IT IS CONSIDERED AT THIS STAGE THAT THIS WAS NOT A PRODUCT PROBLEM. (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO UPDATE SECTION D9, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. IN THE INITIAL REPORT IT WAS REPORTED THAT THE ACTUAL SAMPLE WAS AVAILABLE FOR RETURNED HOWEVER THE ACTUAL SAMPLE IS NO LONGER AVAILABLE. AS A CAUSE OF OCCURRENCE, IT WAS INFERRED THAT THE ACTUAL SAMPLE WAS EXPOSED TO A STRONG IMPACT LOAD DURING BEING HANDLED IN THE DISTRIBUTION PERIOD, WHICH RESULTED IN A CRACK OF THE SAMPLING LINE TUBE LEADING TO THE LEAKAGE. SINCE THE ACTUAL PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, HOWEVER, THE DEFINITE CAUSE OF OCCURRENCE COULD NOT BE DETERMINED. RELEVANT IFU (INSTRUCTIONS FOR USE) REFERENCE: "DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF.(A. SET-UP, CAUTION)" "DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR.(B. PRIMING PROCEDURE WARNINGS)" "IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE. (A. SET-UP, CAUTION)".

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AT THE AT THE TIME OF PRIMING THE FX 25 OXYGENATOR WITH CRYSTALLOID FLUID, THERE WAS A CLEAR LEAKAGE FROM THE OXYGENATOR RECIRCULATION LINE AT THE PROXIMAL POINT OF THE OXYGENATOR. IT SEEMS THE CONNECTOR WAS BROKEN RESULTING IN FLUID LEAKAGE FROM THE RECIRCULATION LINE. THE OXYGENATOR GOT REPLACED BEFORE THE INITIATION OF CPB. THE EVENT OCCURRED PRE-TREATMENT. THE PATIENT FINAL IMPACT WAS NOT HARMED. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265566 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 210831 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male