MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2024

Event Type  malfunction  

Manufacturer Narrative

A1: patient identifier: no patient involvement.A2: age or date of birth: no patient involvement.A3a: sex: no patient involvement.A3b: gender: no patient involvement.A4: weight: no patient involvement.A5: ethnicity: no patient involvement.A6: race: no patient involvement.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: requested, unknown.E3: occupation: requested, unknown.G4: 510(k) no: k071494, k130520.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Confirmation of the provided image found that the purge line of oxygenator was fractured from the port.We have past experienced that similar fracture may have been occurred when momentary external force was applied while the product was cold.The local temperature from february 2023 to the date of occurrence (january 2024) was investigated.It was found that the minimum temperature was below zero.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.Past complaint file found no other similar report of the product with the involved product code/lot# was found.Based on the investigation result, no anomaly was found in the manufacturing records of actual product.As a possible cause of occurrence, based on our past experience, it was inferred that after the product was shipped from the factory, during the distribution process in the cold season, momentary force was applied to the product while it was cooled, causing it to fracture.However, since the condition of damage on the actual product could not be confirmed, it was not possible to identify the cause of this case.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.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The scientific research institute reported that the involved capiox device oxygenator was broken.The problem was detected when unpacking oxygenators from the outer package.On two samples from the same box, there was a broken purge line port and disconnected purge line at the place of its connection with oxygenator body.This could not be occurred during transportation (no visible signs) or removing oxygenator from the box.The hospital is active user of capiox fx oxygenators and handles them with care, so an intentional damage is excluded.The event occurred pre-treatment.There was no patient involvement.

• Brand Name: CAPIOX FX 15 HOLLOW FIBER OXYGENATOR AF
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18813577
• MDR Text Key: 337632224
• Report Number: 9681834-2024-00021
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX*FX15RW40
• Device Lot Number: 221215
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1