MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	1CX*FX05RE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: chief perfusionist.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.A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings.The involved quantity was reported by the user facility as two, however, based on the additional information received on 11sep2020, it was confirmed that the reported two devices were used in two different cases.See mdr 9681834-2020-00185 for the first device reported by the user facility.(b)(4).
Event or Problem Description
The user facility reported the involved capiox reservoir leaked before bypass, during prime.They feel that the issue is that the reservoir outlet curves a bit.The surgery was completed successfully.The product was changed out.There was no blood loss as a result of the issue.The procedure was not delayed.There was no patient injury.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section d9, to update section h3, and to provide the completed investigation results.It was initially reported that the actual sample was available; however, it was confirmed to not be available.Therefore, the device available status has been updated in section d9.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Ifu stats: do not use if the package or device is damaged (e.G.Cracked) or any of the port caps are off.Do not use an oxygenator and reservoir that leaks.Replace it with another capiox fx05 oxygenator and reservoir.Ensure that all connected parts including the luer caps, the lock adapters and the port caps are securely affixed.Loose connections may cause contamination or a blood leak.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 10553912
• Report Number: 9681834-2020-00192
• Device Sequence Number: 2940566
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K071572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 1CX*FX05RE
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 200309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1