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

Catalog Number CX-XRX25403

Device Problem Infusion or Flow Problem (2964)

Patient Problem Blood Loss (2597)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier - requested, not provided. Age & date of birth - requested, not provided. Sex - requested, not provided. Ethnicity - requested, not provided. Race - requested, not provided. Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. 510(k): k130520. The actual sample was received for evaluation. Visual inspection revealed that there were no anomalies. Saline solution was let to flow through the actual device by gravity. Another visual inspection of the actual found that some clots had formed inside the oxygenator module. The actual device, after having been rinsed and dried, was tested for the gas transfer performance by circulating bovine blood (@ hb12g/dl and 37ocin 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 manufacturer specifications. Review of the profusion record revealed the following: after 18:44, there are some points of time when both pao2 and svo2 dropped. Review of the events at those points of time found that the drops in pao2 and svo2 had occurred around the initiation of the extracorporeal circulation. In the record, a star-mark was found to have been put at 20:08, when another extracorporeal circulation was started. Pao2, which was 181mmhg at 20:08 was found to have dropped to 27mmhg at 20:09. There was no indication of the sao2 values from 20:09 to 20:15. A review of the device history record of the product code/lot# combination was conducted with no findings. Ifu states: measure blood gases and make necessary adjustments as follows: control pao2 by changing concentration of oxygen in ventilating gas using gas blender. To decrease pao2, decrease fio2. To increase pao2, increase fio2. 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, with no anomaly with its gas transfer performance. Based on the investigation results, it is likely that blood of which svo2 had become lower entered the oxygenator module at the initiation of the extracorporeal circulation, resulting in the dropped pao2. 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 the involved capiox pack was used during an aortic arch artery replacement case. Due to the slow progress of the procedure, ceases and re-dos of the circulation were repeated. After the third cease of circulation, when the circulation restarted, the o2 transfer performance became degraded. Cooling down did not help the pao2 to be recovered. The actual sample was changed out. The procedure was completed successfully. There was some blood loss due to change-out of the device. The patient was not harmed.

• 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: 8390350
• MDR Text Key: 137833808
• Report Number: 9681834-2019-00031
• 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: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2020
• Device Catalogue Number: CX-XRX25403
• Device Lot Number: 181114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2018
• 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: 03/05/2019 Patient Sequence Number: 1