MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX05; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number 1ZZ*FX05REA

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

This is a bulk product.The actual device has not been returned to the manufacturing facility for evaluation.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.A review of the device history records and product release decision control sheet 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.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Device not returned to manufacturer.

Event Description

The user facility reported thrombus in the capiox fx05 device during pre-cardiopulmonary bypass.Follow up communication with the user facility reported the following information: the circuit clot off prior to cardiopulmonary bypass; it was reported "we also had a circuit clot off prior to cardiopulmonary bypass this am, it was heparinized, had 100 ml prbcs and 30 ml ffp in the prime along with 75 mg cacl and bicarbonate"; "yes, primed with 100 ml blood, 50 ml 25% albumin, 500 units heparin, 5 meq nahco3, and 75 mg calcium according to our usual protocol"; the circuit had thrombus in reservoir and oxy/art filter within 10 minutes; it was reported 100 ml prbcs was lost in the circuit and 30 ml ffp; it was reported this was noted while the patient was being prepped, the entire circuit was removed and had no effect on the patient, just a very rapid re-preparation of a new circuit; it was reported that the patient came down to the or on ecmo; and it was reported that the patient is "ok.".

Manufacturer Narrative

This report is being submitted as follow up # 1 to provide the returned sample evaluation results.The actual sample was returned to the manufacturer for evaluation.Visual inspection upon receipt revealed no anomalies or defects.The actual sample was rinsed and dried.Another visual inspection revealed no anomalies or defects.The actual sample was built into a circuit with tubes, where bovine blood was circulated at each flow rate to determine the pressure drop.The obtained values were confirmed to meet manufacturer specifications.No anomaly was noted.After bovine blood was kept circulating in the circuit for six hours and no anomaly was noted.The blood was rinsed out of the actual sample by saline solution and the oxygenator module was subjected to visual inspection.No presence of blood clot formation was confirmed.The actual sample, after having been rinsed and dried, was verified to be the normal product with no inherent anomaly which could relate to this complaint.There is no evidence that this event was related to a device defect or malfunction.Although the cause for the reported event cannot be definitively determined, based on the provided information that the customer used the prime which contained cacl, bicarbonate, 100ml of prbcs and 30ml of ffp, the combination of these solutions may have led to the formation of clot and/or precipitate.From the available information, however, the definitive cause cannot be determined.The indications which may relate to this complaint can be found in the ifu of this product as follows: "if circulation is to be resumed, recirculation at a low flow rate is recommended.During recirculation, check blood gas pressure.An excessive gas flow may cause low paco2, alkalosis, or blood damage.Where appropriate, introduce blood, plasma and/or blood derived products through quick prime port or any of the luer ports leading to cardiotomy filter after debubbling of oxygenator." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• Brand Name: CAPIOX FX05
• 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: 5705840
• MDR Text Key: 46779666
• Report Number: 9681834-2016-00154
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2016
• 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: 1ZZ*FX05REA
• Device Lot Number: 151007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• 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