MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX25 OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*RX05RW

Device Problem Fracture (1260)

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

Event Date 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

Weight: 8.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the actual product confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report for the involved product code/lot number combination.Terumo medical products (tmp) (importer) registration no: (b)(4) is submitting this report on behalf of ashitaka factory of (b)(4) corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the sampling line tube of the capiox device involved fractured at the joint with reservoir port.The final patient impact was not harmed.The event occurred pre-treatment.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, and to provide the completed investigation results.Visual inspection of the actual sample found that the sampling line and the thermistor probe had been damaged as in the provided image.The provided image was confirmed.It was found that the sampling line connected to the venous blood inlet port of reservoir was damaged.In addition, although there was no description in the reported issue, it was found that the thermistor probe was damaged at the root.Magnifying and electron microscopic inspections of the damaged surface of actual sampling line found that the damaged surface had streak patterns.Therefore, it was inferred that the sampling line was damaged (torn) due to some force.Magnifying and electron microscopic inspections of the damaged surface of actual thermistor probe found that the damaged surface had a smooth shape.Therefore, it was inferred that the damage was caused by an instantaneous force.We have experienced that each similar damage occurred when external force was applied to the product.Shock force was applied to a factory-retained sampling line.It was found that a part of the sampling line was damaged (torn).It was also found that the damaged surface had streak patterns, which was similar to that of the actual sample.Shock force was applied to a factory-retained thermistor probe.It was found that the damaged surface had a smooth shape, which was similar to that of the actual sample.Review of the manufacturing record and the shipping inspection record of the actual sample confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from the same facility.Based on the investigation result, since the sampling line connected to the venous blood inlet port of reservoir and the thermistor probe was damaged, it was likely that the product was damaged due to some force applied during handling of the product, such as the distribution process and the storage environment.However, it was not possible to identify when the product was damaged from the condition of the actual sample, and it was not possible to clarify the cause.

• Brand Name: CAPIOX RX25 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 ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15391327
• MDR Text Key: 305990935
• Report Number: 9681834-2022-00181
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: 04987350763471
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K022115
• 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,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CX*RX05RW
• Device Lot Number: 210806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• 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: 12 MO
• Patient Sex: Male