MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problems Break (1069); Gas/Air Leak (2946)

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

Event Date 03/02/2023

Event Type  malfunction  

Event Description

The user facility reported that priming solution leaked from the purge port and the purge line was broken.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

Patient identifier, dob, weight, ethnicity & race: requested, not provided implanted date: requested, not provided.Explanted date: requested, not provided.Telephone number: unknown.Pma/510k: k130520.Review of the manufacturing record and shipping inspection record of the actual sample found no abnormalities in them.A search of the past complaint file of the involved product code/lot found no other similar observation.Visual inspection of the actual sample found that the purge line connected to the oxygenator had been fractured at the connection with the oxygenator port.Magnifying and electron microscopic inspection found that the fracture surface was smooth.Based on this observation, it was inferred that the fractured was caused by an instantaneous load.There was no contamination of foreign matter or air leading to fracture.The purge line was cut, and the cut surface of the tube was inspected with a magnifier.Any anomaly such as uneven wall thickness was not observed.The inner and outer diameters of the tube were measured, and no differences were found in comparison with those of a current product.Simulation test: we have experienced that a similar fracture may occur when the product in cooled state is subjected to a momentary external load.The temperature of the area where the involved facility locates was checked for the period from (b)(6) 2022 (month/year of production) to (b)(6) 2021(month/year of occurrence) and was confirmed that the lowest temperature reached 0°c.In an assumption that the fracture occurred during transportation or storage, some test samples in a unit box were cooled and then dropped from a height of 1.5 m.The results showed that some of the tubing fractured at the connection with the product.Electron microscopic inspection of the fracture surface found that it was similar to that of the actual sample.The above test condition was set arbitrarily.Based on the condition of the fracture surface of the actual sample and the results of simulation test, following factor was considered as one of possible causes of occurrence, however, the timing of the fracture could not be clearly determined.The product was subjected to a strong impact load during being handled while it was in a cooled state due to the temperature in the distribution process or storage environment in the cold season, which resulted in the fracture.Relevant instructions for use (ifu) reference: "if the product is dropped during set-up, do not use it.Replace with another device.(a.Set-up, caution)".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).

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16660769
• MDR Text Key: 312970656
• Report Number: 9681834-2023-00064
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350701046
• UDI-Public: 04987350701046
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 220823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male