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

Catalog Number CX-XRX10711

Device Problem Infusion or Flow Problem (2964)

Patient Problem Blood Loss (2597)

Event Date 12/31/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted. Explanted date: device was not explanted. 510k - k130520. The actual device was returned for evaluation. Visual inspection did not reveal any obvious anomalies. The actual device, after having been rinsed and dried, was tested for the gas transfer performance by circulating bovine blood in it at the flow rate of 6l/min and 4l/min, under the conditions of fio2
=
100%, v/q
=
1. Both o2 transfer and co2 removal in volume were confirmed to meet the specifications. Review of the profusion records was performed: the circulation was initiated at 9:15 and the actual device was changed out at 17:55. Around 14:40, the arterial blood temperature started to rise while svo2 started to go down. Around 17:15, 8 hours after the initiation of the circulation, when the customer noted pao2 was 170mmhg, there was no significant change in the blood temperature. From this, it is unlikely that the patient's metabolism activated by rewarming affected the reported decrease in pao2. Around 14:00, in spite of a rise given to fio2, svo2 started to go down. From this, it is likely that the gas transfer performance of the actual device started to get degraded due to some factor(s) around that time. A review of the device history record of the reported product code/lot number combination was conducted with no findings. Ifu states: adequate heparinization of the blood is required to prevent it from clotting in the system. Do not reduce heparin during circulation. Otherwise, blood clotting might occur. 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 20l/min for 10 seconds. Do not repeat this flushing technique, even if oxygenator performance is not improved. There is no evidence that this event was related to a device defect or malfunction. The investigation results verified the returned sample was of the normal product. Based off the investigation results, it is likely that some clots formed inside the gas transfer module of the actual device, which hampered blood from having sufficient contact with o2 gas, resulting in the deterioration of the gas transfer performance; the wet-lung phenomenon occurred inside the gas transfer module of the actual device, where water drops accumulated inside the fibers, which hampered blood from having sufficient contact with o2 gas, resulting in the deterioration of the gas transfer performance; or the plasma leak occurred inside the gas transfer module of the actual device, which hampered blood from having sufficient contact with o2 gas, resulting in the deterioration of the gas transfer performance. However, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).

Event Description

The user facility reported that eight hours after the initiation of the circulation, with the involved capiox device; the fio2
=
100%, pao2 dropped down to 170mmhg. The actual sample was changed out to another device and the procedure was completed successfully. The amount of blood loss was reported to be unknown. The procedure was completed successfully. The patient impact was reported to be unknown.

• 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; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 8301413
• MDR Text Key: 134882549
• Report Number: 9681834-2019-00002
• 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: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2019
• Device Catalogue Number: CX-XRX10711
• Device Lot Number: 180205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/04/2019 Patient Sequence Number: 1