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

Catalog Number CX*RX25RW

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Address line: (b)(6) hospital.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 review of device history records and the shipping inspection record of the involved product/lot# combination was conducted with no relevant findings.(b)(4).

Event Description

The user facility reported leakage on the involved capiox rx25 device.When the perfusionists were priming the heat exchanger, they seen water came out from the arterial outlet.The patient was not harmed.The procedure outcome is unknown.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d10, update section h3, provide the completed investigation results, and state that this report has been deemed not fda reportable based on the returned device evaluation results.Visual inspection upon receipt revealed no defects.The water phase of the heat exchanger module was filled with water.With the water outlet port clamped, the heat exchanger module was pressurized by applying an air of 3kgf/cm2 to it from the water inlet port.No leak was confirmed.The blood phase was filled with water.With the blood outlet port clamped, the blood phase was pressurized by applying an air of 2kgf/cm2 to it from the blood inlet port.No leak was confirmed.The investigation results verified that the actual sample was the normal product.There is no evidence that this event was related to a device defect or malfunction and the exact cause for the reported event cannot be definitively determined.The ifu states: "do not use an oxygenator and reservoir that leaks.Replace it with another capiox rx25 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.".

• Brand Name: CAPIOX RX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 8105341
• MDR Text Key: 128388977
• Report Number: 9681834-2018-00209
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• PMA/PMN Number: K040210
• 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: 11/27/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 170613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/27/2018
• Supplement Dates Manufacturer Received: 12/10/2018
• Supplement Dates FDA Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1