BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 13529506 · Received February 14, 2022

    Report

    Report Number
    9681834-2022-00013
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 24, 2022
    Report Date
    February 14, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION-CLINICAL ENGINEER. PMA/510(K)- K071572, K130280. (B)(4). THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE ACTUAL SAMPLE FOUND THAT THE LOCK ADAPTER HAD BEEN COME OFF FROM THE MALE CONNECTOR OF SAMPLING SYSTEM. MAGNIFYING INSPECTION OF THE ACTUAL SAMPLE DID NOT FIND ANY ANOMALY INCLUDING A DEFORMATION ON THE MALE CONNECTOR AND LOCK ADAPTER. THE OUTER DIAMETER OF THE RIB OF MALE CONNECTOR AND THE INNER DIAMETER OF THE LOCK ADAPTER WERE MEASURED AND COMPARED WITH A FACTORY-RETAINED PRODUCT. NO DIFFERENCE WAS FOUND. ELEMENTAL ANALYSIS OF THE SURFACE OF ACTUAL MALE CONNECTOR WAS PERFORMED BY SEM-EDX (SCANNING ELECTRON MICROSCOPE/ENERGY DISPERSIVE X-RAY SPECTROSCOPY). AS A RESULT, SI WAS DETECTED IN THE COCK OF INVOLVED THREE-WAY STOPCOCK, WHICH WAS LIKELY TO BE DERIVED FROM THE SILICONE APPLIED FOR THE PURPOSE OF IMPROVING LUBRICITY. A SIMULATION TEST WAS CONDUCTED, AFTER APPLYING SILICONE TO THE MALE CONNECTOR OF FACTORY-RETAINED SAMPLING SYSTEM, THE FEMALE CONNECTOR WAS CONNECTED AND APPLIED TORQUE FORCE TO THE LOCK ADAPTER. IT WAS FOUND THAT THE LOCK ADAPTER WAS COME OFF. PRODUCT STRUCTURE OF OUR SAMPLING SYSTEM IS DESIGNED SO THAT THE INTERNAL STEP OF LOCK ADAPTER IS CAUGHT ON THE RIBS OF MALE CONNECTOR TO PREVENT LOOSENING WHEN THE FEMALE LUER IS FIXED. THEREFORE, IF THE INTERNAL STEP COMPLETELY OVERCOMES THE RIBS FOR SOME REASON, THE FIXING MAY COME OFF. A REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT RELEASE DECISION CONTROL SHEET OF THE ACTUAL PRODUCT CONFIRMED THAT THERE WERE NOT ANY INDICATIONS OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. MANUFACTURING DATE: SEPTEMBER 7, 2021 BASED ON THE INVESTIGATION RESULT, AS A CAUSE OF OCCURRENCE, IT WAS LIKELY THAT SILICONE APPLIED TO THE COCK OF SAMPLING SYSTEM FOR THE PURPOSE OF IMPROVING LUBRICITY WAS TRANSFERRED TO THE MALE CONNECTOR FOR SOME REASON. THEREFORE, WHEN THE LOCK ADAPTER WAS TIGHTENED, IT CAME OFF. HOWEVER, IT WAS NOT POSSIBLE TO CLARIFY THE TIMING OF THE TRANSFER OF SILICONE TO THE MALE CONNECTOR FROM THE STATE OF ACTUAL SAMPLE. IFU STATES: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE CAPIOX DEVICE INVOLVED PRIMING WAS COMPLETED. WHEN THE RED LOCK OF SAMPLING SYSTEM WAS FASTENED, IT DID NOT LOCK AND CAME OFF. THIS WAS RESOLVED BY ATTACHING A THREE-WAY STOPCOCK TO THE RED LOCK. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735642 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 210907

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown