BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX FX OXYGENATOR

    MDR report key: 22072598 · Received May 22, 2025

    Report

    Report Number
    9681834-2025-00085
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    April 23, 2025
    Report Date
    May 22, 2025
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: NO PATIENT INVOLVEMENT. A2: AGE OR DATE OF BIRTH: NO PATIENT INVOLVEMENT. A3A: SEX: NO PATIENT INVOLVEMENT. A4: WEIGHT: NO PATIENT INVOLVEMENT. A5: ETHNICITY: NO PATIENT INVOLVEMENT. A6: RACE: NO PATIENT INVOLVEMENT. D6A: IMPLANTED DATE: NO PATIENT INVOLVEMENT. D6B: EXPLANTED DATE: NO PATIENT INVOLVEMENT. E1: INITIAL REPORTER NAME: REQUESTED, NOT PROVIDED. E1: PHONE NUMBER: REQUESTED, NOT PROVIDED. G4: 510K: K071572, K130280. THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE MANUFACTURING AND SHIPPING INSPECTION RECORDS OF THE ACTUAL DEVICE SHOWED NO ANOMALIES. A REVIEW OF PAST COMPLAINT FILES FOUND NO OTHER SIMILAR REPORTS FOR THE PRODUCT WITH THE INVOLVED PRODUCT CODE AND LOT NUMBER. TERUMO MEDICAL CORPORATION (TMC) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT AS FOLLOW-UP NO. 1 TO UPDATE SECTION D4, H3 AND PROVIDE THE COMPLETED INVESTIGATION RESULTS. CONFIRMATION OF THE PROVIDED VIDEO REVEALED THAT THE BLOOD INLET PORT OF THE OXYGENATOR WAS WOBBLY WHEN FORCE WAS APPLIED WITH A FINGER. A VISUAL INSPECTION OF THE ACTUAL DEVICE REVEALED THAT THE BLOOD INLET PORT HAD BEEN FRACTURED AT THE ROOT. IN THE VIDEO SHOWING THE DEVICE IN USE, THE BLOOD INLET PORT WAS NOT COMPLETELY FRACTURED, LEADING TO THE INFERENCE THAT THE FRACTURE OCCURRED DURING THE RETURN PROCESS. UPON MAGNIFYING INSPECTION OF THE FRACTURED SURFACE OF THE ACTUAL DEVICE, IT WAS OBSERVED THAT THE SURFACE WAS GENERALLY SMOOTH. RIPPLE PATTERNS WERE FOUND ON THE BOTTOM SIDE OF THE OXYGENATOR, WITH STREAK PATTERNS EXTENDING FROM THEM. NO FOREIGN SUBSTANCES THAT COULD REDUCE THE STRENGTH OF THE DEVICE WERE DETECTED. THESE OBSERVATIONS SUGGEST THAT AN INSTANTANEOUS FORCE WAS LIKELY APPLIED TO THE BLOOD INLET PORT OF THE DEVICE FROM THE BOTTOM SIDE OF THE OXYGENATOR, CAUSING THE FRACTURE TO PROGRESS FROM THE CENTER OF THE RIPPLE PATTERNS TOWARDS THE DIRECTION OF THE STREAK PATTERNS. THE MANUFACTURING AND SHIPPING INSPECTION RECORDS OF THE ACTUAL DEVICE REVEALED NO ANOMALIES. ADDITIONALLY, A REVIEW OF PAST COMPLAINT FILES SHOWED NO OTHER SIMILAR REPORTS FOR THE PRODUCT WITH THE INVOLVED PRODUCT CODE OR LOT NUMBER. BASED ON THE INVESTIGATION RESULT, AS A POSSIBLE CAUSE THAT THE BLOOD INLET PORT WAS LOOSENED, IT WAS LIKELY THAT THE BLOOD INLET PORT WAS ABOUT TO FRACTURE. AS A POSSIBLE CAUSE THAT THE BLOOD INLET PORT WAS FRACTURED, IT WAS INFERRED THAT SOME STRONG IMPACT LOAD WAS APPLIED TO THE BOTTOM SIDE OF OXYGENATOR NEAR THE BLOOD INLET PORT. HOWEVER, FROM THE CONDITION OF ACTUAL DEVICE, IT WAS NOT POSSIBLE TO IDENTIFY EXACTLY WHEN THE IMPACT LOAD WAS APPLIED. RELEVANT INSTRUCTIONS FOR USE (IFU) REFERENCE: 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO CORRECT THE G3 DATE FROM THE FOLLOW UP NO. 1 SUPPLEMENTAL REPORT THAT WAS PREVIOUSLY SUBMITTED. THE CORRECT G3 DATE SHOULD HAVE BEEN MAY 12, 2025.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE INLET PORT OF THE OXYGENATOR WAS FOUND TO BE LOOSE DURING THE DEVICE PREFILLING PROCESS. THE EVENT OCCURRED BEFORE TREATMENT, WITH NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445657 CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ TERUMO CORPORATION, ASHITAKA CX*FX05RW 240726 04987350781772

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown