BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX25 OXYGENATOR

    MDR report key: 14444734 · Received May 19, 2022

    Report

    Report Number
    9681834-2022-00082
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 19, 2022
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350701046
    PMA / PMN Number
    K071494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, OCCUPATION - OTHER, PMA/510(K)- K071494, K130520. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF HE PROVIDED IMAGE CONFIRMED THAT THE PURGE LINE OF THE OXYGENATOR HAD BEEN FRACTURED AT THE CONNECTION WITH THE OXYGENATOR PORT. IT IS KNOWN FROM OUR EXPERIENCE THAT A FRACTURE SIMILAR TO THAT OBSERVED ON THE ACTUAL SAMPLE MAY OCCUR WHEN THE PRODUCT IN A LOW-TEMPERATURE CONDITION IS SUBJECTED TO A MOMENTANEOUS SHOCK LOAD. BASED ON THIS, THE TEMPERATURE IN THE INVOLVED SITE FOR THE PAST ONE YEAR FROM THE DATE OF OCCURRENCE (B)(6) 2022 WAS CHECKED AND CONFIRMED THAT THE LOWEST TEMPERATURE WAS BELOW FREEZING. ASSUMING THAT THE FRACTURE OCCURRED DURING TRANSPORTATION OR STORAGE, MULTIPLE TEST SAMPLES PACKED IN UNIT BOXES WERE COOLED, AND THEN DROPPED FROM 1.5 METER HIGH. AS A RESULT, SOME OF THE TUBES WERE FRACTURED AT THE JOINT WITH THE PRODUCT. THE TEST CONDITION WAS SET DISCRETIONARILY. REVIEW OF THE MANUFACTURING RECORD AND THE PRODUCT-RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT/LOT NUMBER COMBINATION CONFIRMED THERE WAS NO INDICATION OF ANOMALY IN THEM. A SEARCH OF THE COMPLAINT FILE FOUND NO SIMILAR REPORT WITH THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. BASED ON THE RESULTS OF THE INVESTIGATION AND THE DESCRIPTION OF THE COMPLAINT THAT THE FRACTURE WAS FOUND UPON OPENING OF THE BOX, IT WAS PRESUMED THAT THE ACTUAL SAMPLE, WHICH WAS IN A COOLED STATE DUE TO THE AIR TEMPERATURE DURING TRANSPORTATION OR THE STORAGE CONDITION IN THE COLD SEASON, WAS SUBJECTED TO A STRONG SHOCK LOAD WHEN HANDLED, LEADING TO THE FRACTURE OF THE TUBE. HOWEVER, SINCE THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR ANALYSIS, THE DEFINITE CAUSE OF OCCURRENCE COULD NOT BE DETERMINED. RELEVANT IFU (INSTRUCTIONS FOR USE) REFERENCE: IF THE PRODUCT IS DROPPED DURING SET-UP, DO NOT USE IT. REPLACE WITH ANOTHER DEVICE. (A. SET-UP, CAUTION). (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT WHEN OPENING THE CAPIOX FX25 DEVICE EXTERNAL PACKAGE TWO OXYGENATORS WERE FOUND WITH A BROKEN PURGE LINE PORT AND DISCONNECTED PURGE LINE AT PLACE OF CONNECTION WITH OXYGENATOR BODY. THIS COULD NOT BE OCCURRED DURING TRANSPORTATION (NO SIGNS) OR REMOVING OXYGENATOR FROM THE BOX. THE DEFECTS WERE IDENTIFIED THROUGH THE TRANSPARENT PACKAGE. THIS EVENT OCCURRED PRE-TREATMENT. THE PATIENT WAS NOT INJURED DURING THE EVENT AND MEDICAL OR SURGICAL INTERVENTION WAS NOT REQUIRED TO PREVENT INJURY. THE PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189449 CAPIOX FX25 OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA N/A 201207 04987350701046

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown