BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 11884168 · Received May 26, 2021

    Report

    Report Number
    9681834-2021-00088
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 30, 2021
    Report Date
    May 26, 2021
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION- CLINICAL ENGINEER. PMA/510(K)- K130280. THE ACTUAL LOCK ADAPTER SAMPLE WAS ONLY RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED NO BREAKAGE OR SIMILAR ANOMALY IN THE APPEARANCE. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE FOUND NO DEFORMITY OR SIMILAR ANOMALY IN THE APPEARANCE. THE INNER DIAMETER WAS MEASURED. COMPARED TO A CURRENT PRODUCT SAMPLE, NO DIFFERENCE WAS OBSERVED IN THE MEASURED VALUES. REPRODUCTIVE TESTING WAS PERFORMED, AND SILICONE WAS APPLIED TO A MALE CONNECTOR OF A FACTORY-RETAINED SAMPLING SYSTEM, A FEMALE CONNECTOR WAS CONNECTED TO IT, AND THEN A LOCK ADAPTER WAS TIGHTENED UP. AS A RESULT, THE LOCK ADAPTER CAME OFF. IFU STATES: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IT IS LIKELY THAT TO BE THAT SOME KIND OF LUBRICANT WAS ADHERING TO THE MALE CONNECTOR OF THE SAMPLING LINE, AND WHEN THE LOCK ADAPTER WAS RETIGHTENED, IT MAY HAVE GET OVER THE RIB OF THE MALE CONNECTOR AND COME OFF. HOWEVER, WITH NO RETURN OF THE ACTUAL SAMPLING LINE SAMPLE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT. DISLODGEMENT OF LOCK ADAPTER OCCURRED DURING PRIMING. THE LOCKING ADAPTER ON THE ARTERIAL SIDE OF THE SAMPLING LINE CAME OFF EVEN THOUGH NO SPECIAL FORCE WAS APPLIED. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780168 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 201201

    Patients

    Seq Age Sex Outcome Treatment
    1