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

Catalog Number CX-XRX21501

Device Problem Pressure Problem (3012)

Patient Problem Blood Loss (2597)

Event Date 04/23/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The actual device has been returned to the manufacturing facility for evaluation.Visual inspection revealed no obvious anomalies.Air was blown into the gas phase to check for leakage, no plasma leak was confirmed.The actual device was built into a circuit with tubes and saline solution was circulated in it at each flow rate.The pressure drop of the actual device was found to be slightly higher than that of the current product sample.The actual sample was subjected to another visual inspection where clot formation was found.Whether to clot formation was formed during use or during transportation back to the factory could not be confirmed.The actual device was rinsed and dried.Subsequently, it was tested for the gas transfer performance by the circulation of bovine blood at the flow rate of 4l/min and 6l/min, fio2=100%, v/q=1.Both o2 transfer and co2 removal in volume were confirmed to meet manufacturing specifications.The perfusion record was reviewed.Pao2 around 0:30 was 342mmhg and around 1:00 it was noted to have dropped down to 219mmhg.Around 1:30 when the blood gas was determined for the second time, pao2 was 564mmhg.In the perfusion record, there was no indication of the reported drop in pao2 down to 100mmhg.Based on the event log, the actual device was changed out at 1:13.Review of the event log from 0:30 to 1:00 found that at 0:35, the flow rate was decreased from approx.4.5l/min to 4.0l/min.Review of the event log for the time period from the initiation of the circulation till the change-out of the actual device found that svo2 determined by cdi varied from 47 - 91%.At 23:08 the svo2 reached the lowest.A review of the device history record of the involved product code/lot # combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lot# combination.There is no evidence that this event was related to a device defect or malfunction.The actual sample was confirmed to be the normal product with no anomalies in the gas transfer performance.While the exact cause of the reported event cannot be definitively determined based on the available information, the below factors may have occurred simultaneously causing the reported event.Due to temporary lowering the blood flow rate, the circulation flow rate became insufficient against the patient's body surface area.This caused a decrease in svo2 and then in pao2.Clots started to form and hampered blood from having sufficient contact with o2 gas and the gases from being transferred properly.Due to this, the volume of o2 supply became insufficient for the volume of the patient's o2 consumption, causing a decrease in svo2 and then in pao2.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported insufficient gas exchange in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information; (1) the case was with a hyperlipidemic patient with the bsa of 2.11m2; (2) during the extracorporeal circulation, a significant decrease was seen in the oxygen partial pressure value; (3) pao2 at 24:30 was 324mmhg, which dropped down to 219mmhg at 1:00 and finally down to 100mmhg; (4) an increases in the gas flow rate and fio2 did not work; (5) the actual sample was changed out; and (6) the amount of blood loss is 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6583862
• MDR Text Key: 75717840
• Report Number: 9681834-2017-00096
• 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
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: CX-XRX21501
• Device Lot Number: 161109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2016
• 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
• Patient Age: 64 YR
• Patient Weight: 92