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

Catalog Number CX*RX05RW

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 03/09/2019

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Reporter name: unknown.Health professional: unknown.Initial reporter occupation: unknown.510(k): k122590.The involved device was not returned for evaluation.Therefore, the investigation was based on user facility information and evaluation of the retention sample from the involved product code/lot# combination.Visual inspection revealed there were no anomalies, such as a break, in the appearance.The sample was tested for its gas transfer performance in accordance with the manufacturer shipping inspection protocol.Bovine blood arranged to hb12.0 g/dl, temperature 37oc., ph:7.4, svo2:65% and pvco2:45mmhg was circulated in the oxygenator module under the following conditions: @ v/q=1, fio2=100% and the flow rate of 2l/min.And 1/min.The following results were found: o2 transfer: @2l/min.= 118ml/min.@1l/min.= 68ml/min.Co2 removal: @2l/min.= 97ml/min.@1l/min.= 57ml/min.No anomalies were revealed in the gas transfer performance of the retention sample, with the obtained values meeting the manufacturer specifications.A review of the device history record and the product release decision control sheet of the reported product code/lot number 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.This investigation results verified the retention sample was of the normal product.However, with no device return 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 the perfusionist changed out the capiox oxygenator; after initiating the bypass initial po2 was 250, and after thirty minutes po2 dropped down to 45 mmhg.The procedure outcome and patient outcome was unknown.Blood loss was not reported.

• 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
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 8458989
• MDR Text Key: 140140098
• Report Number: 9681834-2019-00043
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350763471
• UDI-Public: 04987350763471
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K022115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: CX*RX05RW
• Device Lot Number: 180912
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2019
• Initial Date FDA Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2018
• 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
• Patient Outcome(s): Other