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

Catalog Number CX-XRY10901

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The 510(k): k130520.The actual device was not returned for evaluation.However, a photograph of the involved device was provided for evaluation.Therefore, the investigation was based upon evaluation of user facility information, a photograph of the involved device and a retention sample of the involved product code/lot# combination.The photograph revealed the presence of a liquid inside the actual device on the gas-out side.The retention sample from the same fiber lot# as the one used for the actual device was subjected to visual inspection and it was confirmed no anomalies, such as a break.The retention sample was circulated with bovine blood at the flow rate of 5l/min., and at the back pressure of 500mmhg.For six hours.After this, gas was swept into the retention sample from the gas-in side.No plasma leak occurred.The ifu states: a phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers.This may occur when oxygenators are used for a longer period of time.If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance.Increase gas flow rate, to 15l/min for 10 seconds.Do not repeat this flushing technique, even if oxygenator performance is not improved.A review of the device history record of the involved product code/lot number combination revealed no findings.A search of the complaint file found no previous report of this nature with the involved product /lot# combination.The investigation results verified that the retention sample from the same fiber lot number as the one used for the actual device was the normal product with no occurrence of plasma leak.As a cause of the reported plasma leak, it is likely due to a change in the blood properties due to some factor(s), a surface-active substance may be generated in blood.This may lead the balance of the surface tension between the gas and blood which is kept at the micro pores on the surface of the fibers to be upset, resulting in plasma leak.However, it is difficult to determine the definitive cause of this complaint.(b)(4).

Event Description

The user facility reported a plasma leak with the involved capiox fx device.A plasma leak occurred four and half hours after the initiation of the circulation.The actual sample was changed out.The amount of blood loss is unknown.The procedure outcome is unknown.The patient passed away two days after the operation.It was reported by the involved hospital that the death did not have any cause-and -effect relationship with this complaint.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: mark vornheder ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7766670
• MDR Text Key: 116526672
• Report Number: 9681834-2018-00139
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: CX-XRY10901
• Device Lot Number: 171116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2017
• 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
• Treatment: CELL SAVER & HAS II
• Patient Outcome(s): Other
• Patient Age: 76 YR