BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 9552613 · Received January 6, 2020

    Report

    Report Number
    9681834-2019-00229
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 5, 2019
    Report Date
    January 6, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE DEVICE RETURN DATE IN SECTION D10, UPDATE SECTION H3, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A CRACK HAD OCCURRED ON THE ROOT OF THE FEMALE LUER CONNECTOR LOCATED BETWEEN THE YELLOW AND BLUE COCKS, AND THE BLUE COCK SIDE HAD COME OFF THE CRADLE. AN ATTEMPT TO INJECT COLORED SALINE SOLUTION INTO THE ACTUAL SAMPLE WITH SYRINGE DEMONSTRATED THAT THE SALINE SOLUTION LEAKED FROM THE CRACK. SUBSEQUENTLY, WHEN THE SALINE SOLUTION WAS ASPIRATED WITH SYRINGE, AIR WAS DRAWN THROUGH THE CRACK INTO THE ACTUAL SAMPLE. MAGNIFYING INSPECTION WITH CCD FOUND WHITENING PHENOMENON (FINE CRAZING) AROUND THE STARTING POINT OF THE CRACK. IT MAY OCCUR WHEN RESIN MATERIAL IS SUBJECTED TO EXTERNAL FORCE AND STRETCHED. BASED ON THE DISLOCATION OF THE BLUE COCK SIDE FROM THE CRADLE AND THE WHITENING PHENOMENON AROUND THE CRACK, IT IS LIKELY THAT WHEN ATTEMPTING TO REMOVE THE SAMPLING SYSTEM FROM THE RESERVOIR, THEY PULLED UP THE BLUE COCK SIDE DIAGONALLY, AND THIS CAUSED THE ROOT OF THE FEMALE LUER CONNECTOR ON THE YELLOW COCK TO BE EXPOSED TO BENDING FORCE, RESULTING IN THE GENERATION OF THE CRACK. REPRODUCTIVE TESTING WAS PERFORMED USING FACTORY-RETAINED SAMPLING SYSTEM SAMPLES. AS A RESULT, IT WAS FOUND THAT A CRACK OCCURRED SOMETIMES ON THE SAME LOCATION AS THE CRACK ON THE ACTUAL SAMPLE. IN ADDITION, MAGNIFYING INSPECTION OF THE CRACKED SECTION OBSERVED THAT WHITENING PHENOMENON OCCURRED. IFU STATES: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. DO NOT USE AN OXYGENATOR AND RESERVOIR THAT LEAKS. REPLACE IT WITH ANOTHER CAPIOX FX25 OXYGENATOR AND RESERVOIR. 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 IS LIKELY THAT THE SAMPLING SYSTEM WAS SUBJECTED TO BENDING FORCE WHILE BEING REMOVED FROM THE RESERVOIR, RESULTING IN THE GENERATION OF THE CRACK. DUE TO THE CRACK, IT WAS LIKELY THAT AIR WAS DRAWN IN THE LINE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K): K130520. THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD AND PRODUCT RELEASE DECISION CONTROL SHEET OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AIR CAME INTO THE LINES DURING PRIMING OF THE INVOLVED CAPIOX DEVICE. THEY REALIZED THAT THE YELLOW KEY AT THE SAMPLING PIECE WAS BROKEN. THE EVENT OCCURRED PRE-TREATMENT, THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17842 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 180912

    Patients

    Seq Age Sex Outcome Treatment
    1