BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX RX15

    MDR report key: 10372189 · Received August 6, 2020

    Report

    Report Number
    9681834-2020-00153
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    July 16, 2020
    Report Date
    August 6, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350771056
    PMA / PMN Number
    K051997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PHONE NUMBER- REQUESTED, NOT PROVIDED. THE ACTUAL SAMPLE HAS BEEN RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT STERILE BAG WAS UNOPENED, AND A HOLE HAD BEEN GENERATED ON THE NONWOVEN FABRIC. THE UNIT BOX WITH CUSHIONING MATERIAL THAT HAD CONTAINED THE ACTUAL SAMPLE WAS VISUALLY INSPECTED AND FOUND THAT IT HAD BEEN DEFORMED IN MULTIPLE POINTS. IT COULD NOT BE CLARIFIED WHEN THE UNIT BOX WAS DEFORMED. MAGNIFYING INSPECTION OF THE HOLE REVEALED THAT IT HAD BEEN MADE FROM THE INSIDE OF THE STERILE BAG. THE THICKNESS OF THE STERILE BAG MATERIAL WAS MEASURED AND CONFIRMED TO BE EQUIVALENT TO THAT OF A MANUFACTURER RETENTION SAMPLE. THE SAMPLING SYSTEM CONTAINED IN THE STERILE BAG, ON THE TOP OF RESERVOIR WAS CONFIRMED TO HAVE BEEN LOCATED BENEATH THE POINT ON THE NONWOVEN FABRIC WHERE THE HOLE WAS GENERATED. BASED ON THIS, THE SAMPLING SYSTEM WAS INSPECTED VISUALLY AND CONFIRMED TO HAVE NO BURRS THAT COULD MAKE A HOLE ON THE NONWOVEN FABRIC. A REVIEW OF THE DEVICE HISTORY RECORD AND THE PRODUCT RELEASE JUDGEMENT RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION REVEALED NO FINDINGS. IFU STATES: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. 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 SINCE THE UNIT BOX WAS DEFORMED, IT IS LIKELY THAT AN EXCESSIVE LOAD WAS APPLIED WHILE THE ACTUAL SAMPLE WAS IN THE UNIT BOX, CAUSING A HOLE AT THE POINT WHERE THE RESERVOIR WAS IN CONTACT WITH THE STERILE BAG. IT IS LIKELY TO BE DUE TO HANDLING DURING STORAGE PERIOD WHY THE ACTUAL SAMPLE WAS SUBJECTED TO SUCH AN EXCESSIVE LOAD. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. 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 · 1

    THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX DEVICE WAS USED PRE-TREATMENT. AFTER THEY OPENED THE BOX, THE PERFUSIONIST FOUND ASEPTIC PACKAGE BROKEN. THE PROCEDURE OUTCOME AND PATIENT OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840656 CAPIOX RX15 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 191011C 04987350771056

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR