MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX*FX05RE

Device Problem Infusion or Flow Problem (2964)

Patient Problem Blood Loss (2597)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was received for evaluation.Visual inspection revealed there were no anomalies.The actual sample, after having been rinsed and dried, was built into a circuit with tubes and bovine blood arranged to hct.At 35% and temperature of 37oc.Was circulated at each flow rate and the pressure loss was determined.The obtained values were confirmed to be within the specifications.No obstruction inside the oxygenator module was verified.During this test, the flow rate was found to be able to reach 1.5 l/min, which is the maximum value for fx05.The difficulty reported by the customer in getting the flow rate above 300-400 ml was not reproduced.Water was flushed through the blood phase.There was no presence of clots forming inside the oxygenator module.A review of the device history record of the product code/lot# combination was conducted with no findings.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, the actual sample, was found to be the normal product with no issue related to insufficient flow rate.It is likely the distal end of the cannula had contact with the arterial wall, hindering blood from flowing sufficiently; or there was a kink generated on a tube in the circuit.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 during cardiopulmonary bypass, the target flow of the involved capiox oxygenator was 1l/min, however, they could not get the flow above 300-400ml.The event did result in about a 3-minute delay in beginning or continuing the surgical procedure.The product was changed out, and the surgery was successfully completed.There was 35ml of blood loss as a result of the reported event.Additional information was received on november 14, 2018.The user facility does not think there was a problem with the oxygenator.The patient's flow requirement was 1.0 lpm and they had difficulty reaching the required flow rate at the initiation of bypass (was only able to flow ~400 ml/min) and had a high line pressure.The perfusionist notified the surgeon, they came off bypass and the surgeon re-positioned the arterial cannula which resulted in the ability to flow a little higher but still had a high line pressure.The perfusionist clamped the arterial line at the outlet of the oxygenator, and tried flowing through the recirculation line and was able to flow at least 800 ml/min through the oxygenator and the recirculation line.The surgeon re-positioned the cannula twice more but instead of attempting to initiate bypass after the third time re-positioning the cannula, they decided to change out the oxygenator in the event that there was a problem with flowing through the oxygenator.After changing out the oxygenator, they initiated bypass again and were able to reach the target flow of 1.0 lpm, however, the perfusionist said the line pressure was still a bit high.They rinsed out the original oxygenator and did not see any clot, the perfusionist said the fiber bundle was clean.They do not think the oxygenator was the cause of the flow restriction and high back pressure issue.

• Brand Name: CAPIOX HOLLOW FIBER OXYGENATOR/ARTERIAL FILTER
• 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: 8119499
• MDR Text Key: 128876282
• Report Number: 9681834-2018-00213
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350781758
• UDI-Public: 04987350781758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: CX*FX05RE
• Device Lot Number: 180606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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