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

Catalog Number CX*RX25RW

Device Problem Filtration Problem (2941)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/25/2017

Event Type  Injury  

Manufacturer Narrative

The actual device was discarded by the involved facility.Therefore, a factory retained sample from the reported product code/lot number combination was evaluated.Visual inspection confirmed the retention sample had no anomalies.Bovine blood was circulated in the retention sample.No anomalies were found that would trigger a clot formation.The provided images of the actual sample were reviewed; it was difficult however to confirm the presence of the reported clots inside the device.A review of the device history record and shipping inspection record from the reported product code/lot number combination was conducted with no relevant findings.The investigation verified the retention sample was the normal product.With no returned of the actual device the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported clots were found in the reported device.During an cabg, avr case, it started with a beating heart cabg, the perfusionist used primed pump (oxygenator) to collect shed blood into the reservoir, after 30 minutes the perfusionist found clots in the reservoir.Patients act- 528/640 secs.Heparin was added when priming.Perfusionist changed the oxygenator before performing the bypass, there was no harm to the patient.

• 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: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 7138382
• MDR Text Key: 95504838
• Report Number: 9681834-2017-00250
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04987350769572
• UDI-Public: 04987350769572
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K040210
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CX*RX25RW
• Device Lot Number: 170715
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2017
• 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
• Patient Outcome(s): Required Intervention