BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 10337263 · Received July 29, 2020

    Report

    Report Number
    9681834-2020-00138
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    June 29, 2020
    Report Date
    July 29, 2020
    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

    PMA/510(K)- K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED NO VISIBLE ANOMALY. COMPARED TO A CURRENT PRODUCT SAMPLE, IT WAS FOUND THAT CARDIOTOMY FILTER HAD BEEN SWELLED. VISUAL INSPECTION OF THE LID OF THE RESERVOIR REVEALED THAT BLOOD WAS ADHERED UP TO THE UPPER END OF THE CARDIOTOMY FILTER. THE CARDIOTOMY FILTER AND THE DEFOAMER INSIDE IT WERE SUBMERGED IN PHYSIOLOGICAL SALINE SOLUTION, AND THEN INSPECTED VISUALLY. FORMATION OF BLOOD CLOTS WAS OBSERVED ON SOME PARTS; HOWEVER, IT WAS CONFIRMED THERE WAS NO ANOMALY THAT COULD CAUSE CLOGGING OF THE RESERVOIR IN THE REMAINDER PART. THE CARDIOTOMY FILTER AND THE DEFOAMER INSIDE IT WERE RINSED, THEN SOME PARTS WITH NO ADHESION OF BLOOD CLOTS WERE INSPECTED WITH SEM. NO DIFFERENCE WAS CONFIRMED COMPARED TO THOSE OF A CURRENT PRODUCT SAMPLE. 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. THE CAUSE OF THE CLOGGING COULD NOT BE READ BY REVIEWING THE PUMP RECORD. IFU STATES: THE CAPS OF UNUSED PORTS SHOULD BE LEFT IN PLACE. THIS AVOIDS CONTAMINATION AND PREVENTS LEAKAGE OF BLOOD. MAKE SURE THE CAPS OF UNUSED LUER PORTS ARE TIGHTENED FIRMLY TO PREVENT THE LEAKAGE. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE INVESTIGATION RESULTS VERIFIED THE RETURNED SAMPLE WAS OF THE NORMAL PRODUCT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX FX25 WAS USED DURING THE PROCEDURE. LEFT ATRIUM MYXOMA CASE. DURING ECC THE CARDIOTOMY PART OF THE VENOUS RESERVOIR WAS CLOGGED, THE RESERVOIR LEVEL REACHED THE HIGHEST, AND THE BLOOD IN THE RESERVOIR TEMPORARILY OVERFLOWED. DURING THE ECC, ACT DECREASED TO 350, AND HEPARIN WAS ADDED TO IMPROVE IT TO 490. THEY USED THE CELL SAVER BLOOD RESERVOIR AND THE VEIN SOFT RESERVOIR URGENTLY TO MAINTAIN THE ECC AND MANAGED TO TURN OFF THE PUMP. THE OPERATION FINISHED SAFELY. THE ESTIMATED BLOOD LOSS WAS 200ML. THE PATIENT WAS NOT HARMED. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804429 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 200120

    Patients

    Seq Age Sex Outcome Treatment
    1