BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 11947640 · Received June 7, 2021

    Report

    Report Number
    9681834-2021-00099
    Event Type
    Malfunction
    Date Received
    June 7, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 7, 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 SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE LOCK ADAPTER HAD COME OFF THE MALE CONNECTOR OF THE SAMPLING SYSTEM. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE DID NOT FIND ANY VISIBLE ANOMALY, INCLUDING DEFORMITY, IN THE MALE CONNECTOR OR IN THE LOCK ADAPTER. THE OUTER DIAMETER OF THE RIB OF THE MALE CONNECTOR AND THE INNER DIAMETER OF THE LOCK ADAPTER WERE MEASURED. COMPARED WITH A CURRENT PRODUCT SAMPLE, NO DIFFERENCE WAS OBSERVED IN THE MEASURED VALUES. THE SURFACE OF THE MALE CONNECTOR WAS SUBJECTED TO ELEMENTAL ANALYSIS BY SEM-EDX (SCANNING ELECTRON MICROSCOPE / ENERGY DISPERSIVE X-RAY SPECTROSCOPY). THE RESULT SHOWED THE PRESENCE OF SI, WHICH IS LIKELY TO BE DERIVED FROM THE SILICONE APPLIED TO THE SWITCH COCKS OF THE THREE-WAY STOPCOCK TO IMPROVE THE LUBRICITY OF THEM IN THE MANUFACTURING PROCESS. 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. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. IFU STATES: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. IT WAS LIKELY THAT THE SILICON, WHICH IS APPLIED TO THE SWITCH COCKS OF THE SAMPLING SYSTEM TO IMPROVE THE LUBRICITY, WAS TRANSFERRED TO THE MALE CONNECTOR PART DUE TO SOME FACTORS. AFTERWARD, THE LOCK ADAPTER, WHEN RE-TIGHTENED, MAY HAVE GOT OVER THE RIB OF THE MALE CONNECTOR IN LUBRICATED STATE AND CAME OFF. HOWEVER, FROM THE AVAILABLE INFORMATION INCLUDING THE STATE OF THE ACTUAL SAMPLE, IT COULD NOT BE DETERMINED WHEN SILICONE WAS TRANSFERRED TO THE MALE CONNECTOR. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CAPIOX DEVICE WAS USED PRE-TREATMENT, DURING PRIMING, THE LURE ADAPTOR OF THE SAMPLING SYSTEM CAME OFF. THE SAMPLING SYSTEM IN QUESTION WAS REPLACED WITH ANOTHER ONE THAT HAD BEEN PROVIDED BEFOREHAND AND THE OPERATION WAS CARRIED OUT. THE PROCEDURE OUTCOME WAS NOT REPORTED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844242 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200907

    Patients

    Seq Age Sex Outcome Treatment
    1