MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX05; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX05RW

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- requested, not provided.510(k) - k130280.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.For a review of the device history record and the product release judgement control record of the involved product code/lot number combination revealed no findings.(b)(4).

Event Description

The user facility reported that the involved capiox device was used during the procedure.Surgical management of patient with regular tetralogy of fallot with persistent ductus arteriosus and hyper pulmonary flow in the context of poly malformative syndrome.At the time of the operation, a leak was observed at the outlet of the oxygenator from the extracorporeal circulation.They plugged the leak to successfully complete the operation.Risk of hypovolemia; patient blood loss was bout 70ml.There was no harm to the patient.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update sections a2, d10 and h3, and to provide the completed investigation results.It was initially reported that the actual sample was available for evaluation; however, it was confirmed that the sample is not available.Therefore, section d10 has been updated.A correction to section is being provided to section a2, it was initially reported the patient was 7 months old; however, it was confirmed the patient was 8 months old.Therefore, section a2 has been updated.A4: weight - 6.2kg.Patient height: 62 cm.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Ifu states: do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir.Band all connections in the circuit.It is likely that a route of leak had been generated at the connection between the outlet port and tubing.However, with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

Event Description

Additional information was received on 27jul2020.The event did not significantly delay the procedure.Patient had normal karyotype.Following the event, the patient was treated as planned.

• Brand Name: CAPIOX FX05
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10156896
• MDR Text Key: 197351114
• Report Number: 9681834-2020-00094
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781772
• UDI-Public: 04987350781772
• Combination Product (y/n): N
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: CX*FX05RW
• Device Lot Number: 181031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 MO
• Patient Weight: 6