BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX05

    MDR report key: 10470485 · Received August 31, 2020

    Report

    Report Number
    9681834-2020-00172
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    August 7, 2020
    Report Date
    August 31, 2020
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    DTZ
    UDI-DI
    04987350781772
    PMA / PMN Number
    K071572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE & DATE OF BIRTH - AGE: REPORTED TO BE (B)(6) YEARS. DATE OF BIRTH: REQUESTED, NOT PROVIDED. UDI - NOT REQUIRED FOR PRODUCT CODE. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. 510(K) - K130280. THE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND MAGNIFYING INSPECTIONS OF THE ACTUAL SAMPLE REVEALED THAT THE BLOOD INLET PORT HAD BEEN CRUSHED FROM THE OUTSIDE TO THE INSIDE. THEREFORE, IT WAS CONSIDERED THAT SOME SORT OF LOAD WAS APPLIED TO THE INLET PORT. THERE WAS NOT ANY OTHER ANOMALY, SUCH AS A BREAKAGE, IN THE REMAINDER OF THE ACTUAL SAMPLE. VISUAL AND MAGNIFYING INSPECTIONS OF THE BLUE CAP THAT HAD BEEN ATTACHED TO THE INLET PORT CONFIRMED IT HAD NO ANOMALY IN THE APPEARANCE SUCH AS DEFORMITY. THEREFORE, IT WAS LIKELY THAT THE BLOOD INLET PORT WAS EXPOSED TO SOME LOAD AFTER THE BLUE CAP WAS REMOVED FROM IT. A FACTORY-RETAINED SAMPLE FROM THE INVOLVED PRODUCT CODE WAS CHECKED FOR THE POSITIONAL RELATIONSHIP BETWEEN THE OXYGENATOR AND CUSHIONING MATERIAL WHEN THE OXYGENATOR WAS CONTAINED INSIDE THE UNIT BOX. IT WAS CONFIRMED THAT THE BLOOD INLET PORT WAS NOT IN CONTACT WITH THE CUSHIONING MATERIAL. REPRODUCTIVE TESTING WAS PERFORMED, AND THE BLOOD INLET PORT OF AN OXYGENATOR SAMPLE WAS HIT BY A HARD OBJECT. AS A RESULT, THE BLOOD INLET PORT BECAME CRUSHED INWARD. 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. IFU STATES: DO NOT USE IF THE PACKAGE OR DEVICE IS DAMAGED (E.G. CRACKED) OR ANY OF THE PORT CAPS ARE OFF. IF THE PRODUCT IS DROPPED DURING SET-UP , DO NOT USE IT. REPLACE WITH ANOTHER DEVICE. 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 BLOOD INLET PORT OF THE ACTUAL SAMPLE WAS HIT BY A HARD OBJECT AND DEFORMED. FROM THE AVAILABLE INFORMATION, HOWEVER, IT IS DIFFICULT TO DETERMINE THE CAUSE OF OCCURRENCE OF THE PROBLEM. HOWEVER, 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 FX05 OXYGENATOR INLET WAS DAMAGED PRE-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938170 CAPIOX FX05 OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA NA 191213C 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1