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

Catalog Number CX-XRY20601

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

Udi number for this product code is not required.The actual device was discarded by the involved facility.Therefore the investigation was limited to the information provided by the user facility as well as a photo provided by the user facility.The photo taken during the use of the actual device.The following findings were obtained by the photo.A blood leak was noted at the joint of the tube and the blood outlet port on the oxygenator module.The tube seemed to have been inserted over the port all the way sufficiently with no obvious anomalies noted on the shrink tube attached to the joint.A review of the device history record from the reported product code/lot number combination was conducted with no relevant findings.A search of the complaint file found no other report with the involved product code/lo number combination.There is no evidence that this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, the following factors can be inferred.Due to some factor(s), such as a way of tube handling, the segment of the tube around the joint between the tube and the port was subjected to some bending force.By this force, the tube slipped off the port slightly and the sticking force acting between the tube and the port was degraded, resulting in the generation of a channel of a leak.The segment of the blood outlet port covered with the shrink tube had some anomaly such as a crack, resulting in the reported leak.(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 leakage in the capiox device during a procedure.Follow up communication with the user facility confirmed the following information: a blood leak was noted at the joint between the tube and the blood outlet port on the oxygenator module; the customer found the leak soon before the completion of the extra corporeal circulation and decided not to change out the device; the procedure was finished using the actual device; and blood loss was approximately 2 cc.

• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6833481
• MDR Text Key: 84098388
• Report Number: 9681834-2017-00180
• 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: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: CX-XRY20601
• Device Lot Number: 170406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2017
• 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