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

Catalog Number ZZ*FX15RW40

Device Problem Pressure Problem (3012)

Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record and shipping inspection record of the involved product code/lot number combination revealed no findings.(b)(4).

Event Description

The user facility reported the pressure at the beginning of the perfusion was in a normal range, then a steady inlet pressure increased up to over 500 mmhg.The heart volume could not be sustained, therefore the oxy was changed out and exchanged with an maquet oxy.Afterwards the oxygen production was in the normal range, act values was in the desired range.Blood loss was approximately 140 ml.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information and the completed investigation.It was initially reported the actual device was available.However, it was confirmed the actual device is not available.Section now reflect the actual device is not available.The retention sample from the involved product code/lot# combination was evaluated.Visual inspection revealed no anomalies.The retention sample was built into a circuit with tubes.Bovine blood (hct35% and temp.37oc) was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the factory's specifications.There was no indication of obstruction in the oxygenator module.After the test the bovine blood was circulated for 6 hours.No obstruction occurred inside the oxygenator module.When the circulation was ceased, the retention sample was flushed with water.Any clots which could lead the pressure inside the oxygenator module to increase were not found inside the retention sample.There is no evidence that this event was related to a device defect or malfunction.The investigation result verified that the retention sample was the normal product.As a cause of this complaint, based on the gradual increase in the pressure drop, it is likely that some clots were formed inside the actual sample and caused the pressure inside the oxygenator module to increase.With the absence of the actual sample to evaluate, however, it is difficult to determine the definitive cause of this complaint from the available information, including the information in the perfusion record.The exact cause of the reported event cannot be definitively determined based on the available information.

• 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
• MDR Report Key: 7259790
• MDR Text Key: 99593749
• Report Number: 9681834-2018-00017
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: ZZ*FX15RW40
• Device Lot Number: 161124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 62