MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX05 OXYGENATOR WITH RESERVOIR (LF PORT); OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number	CX*RX05RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was received for evaluation.Visual inspection revealed no anomalies.The actual sample, after having been rinsed and dried, was built into a circuit with tubes and saline solution was circulated in it at 1.5l/min., which is the maximum flow rate for rx05.No leak was observed.Subsequently, the blood phase of the oxygenator module was filled with saline solution.With the blood outlet port side clamped, an air pressure of 2kgf/cm2 was applied to the blood phase from the blood inlet port.No leak was observed.A review of the device history record and product release decision control sheet of the involved product code/lot number combination was conducted with no findings.Ifu states: do not use an oxygenator and reservoir that leaks.Replace it with another capiox rx05 oxygenator and reservoir.Band all connections in the circuit.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.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.It is likely that the priming solution leaked at the joint of the port and the tube.However, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that the perfusionist found water out of gas out port on involved capiox device during priming.The event occurred pre-treatment; the procedure outcome and patient impact was not reported.

• Brand Name: CAPIOX RX05 OXYGENATOR WITH RESERVOIR (LF PORT)
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8964741
• Report Number: 9681834-2019-00159
• Device Sequence Number: 13990930
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: 04987350763471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2019

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: 10/31/2021
• Device Catalogue Number: CX*RX05RW
• Device Lot Number: 181122C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 16