BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 15329230 · Received August 31, 2022

    Report

    Report Number
    9681834-2022-00168
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Report Date
    August 31, 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

    PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED. PATIENT SEX: REQUESTED, NOT PROVIDED. WEIGHT: REQUESTED, NOT PROVIDED . ETHNICITY: REQUESTED, NOT PROVIDED. RACE: REQUESTED, NOT PROVIDED. DATE OF EVENT: REQUESTED, NOT PROVIDED. LOT NUMBER: REQUESTED, NOT PROVIDED. EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI: N/A AS THIS PRODUCT IS NOT EXPORTED TO THE US MARKET. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION: CLINICAL ENGINEER. PMA/510(K): K130280. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL SAMPLE WAS NOT RETURNED TO ASHITAKA FACTORY FOR EVALUATION. THE PROVIDED PHOTO WAS CONFIRMED. IT WAS FOUND THAT THE LOCK ADAPTER WAS DISCONNECTED FROM THE MALE CONNECTOR OF SAMPLING SYSTEM. SINCE THE LOT NUMBER WAS UNKNOWN, THE MANUFACTURING RECORD AND THE SHIPPING INSPECTION RECORD COULD NOT BE REVIEWED. AS A POSSIBLE CAUSE OF THIS COMPLAINT, FROM OUR PAST EXPERIENCES, IT WAS INFERRED THAT SINCE SOME KIND OF LUBRICANT WAS ADHERED TO THE MALE CONNECTOR, THE LOCK ADAPTER WAS DISCONNECTED WHEN IT WAS TIGHTENED. HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, IT WAS NOT POSSIBLE TO CONFIRM WHETHER THERE WAS ANY ADHERING SUBSTANCE, AND THE CAUSE OF OCCURRENCE COULD NOT BE CLARIFIED. RELEVANT IFU REFERENCE: " DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF.(A. SET-UP, CAUTION)" 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 · 0

    THE USER FACILITY REPORTED THAT DURING PRIMING, IT WAS FOUND THAT THE LOCK ADAPTER OF SAMPLING SYSTEM WAS DISCONNECTED. THE LOCK ADAPTER WAS JUST PUSHED IN AND WAS USED. THE PROCEDURE OUTCOME WAS NOT REPORTED AND THE PAITENT WAS NOT HARMED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088656 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown