MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF; OXYGENTOR

Catalog Number CX*FX25RW

Device Problem Hole In Material (1293)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2015

Event Type  malfunction  

Manufacturer Narrative

This section was completed by the manufacturer per cfr 803.52(f) (11) because the information was not initially completed by the user facility.The actual device has not been received by the manufacturing facility for evaluation.A follow up report will be submitted within 30 days from the date that this report was sent.For this reason code was used in the conclusions section.A review of the device history record and product release decision control sheet of the involved product/lot# combination confirmed there were no indications of production-related anomalies.A search of the complaint file found no report with the involved product code/lot# combination.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.Actual device not returned.

Event Description

The user facility reported a hole in the polycarbonate housing of the oxygenator.Follow up communication with the user facility reported the following information: (1) the reported hole was noted to be surrounded by blackened material; and (2) there was not patient involvement.

Manufacturer Narrative

This report is being submitted as follow-up no.2 for mfg.Report no.9681834-2015-00205 to provide the return sample evaluation results.The actual sample was returned to the manufacturing facility for evaluation.Visual inspection was conducted and was noted to meet manufacturing specifications.The actual sample was built into a circuit with a roller pump and tubes and the circuit was circulated with saline solution at the flow rate of approx.5.0l/min.No leak was confirmed.The actual sample was filled with saline solution and pressurized at approx.2.0kgf/cm2.No leak was observed.The actual sample was disassembled for further inspection of the air bubble.No presence of a foreign substance was found adhering inside the bubble.A review of the device history record and product release decision control sheet of the involved product code lot # combination confirmed that there no production related problems.A search of the complaint file found no previous reports of this nature with the involved product code lot # combination.The exact cause of the reported event cannot be determined based upon the available information.The evaluation results verified that the actual sample was of normal product.There are many complex clinical variables that may have affected the reportedly observed conditions during the procedure.However, there is no indication that the reported event was related to a product malfunction or defect.All currently available information has been placed on file by qa at the manufacturing facility for appropriate tracking, trending, and follow up.(b)(4).

Event Description

This report is being submitted as follow-up no.2 for mfg.Report no.9681834-2015-00205 to provide the return sample evaluation results.

Manufacturer Narrative

As stated, this report is being submitted as follow-up no.1 for mfg.Report no.9681834-2015-00205.The actual device was returned to the manufacturing facility and the evaluation is currently ongoing.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.For this reason (b)(4) was used in the conclusions section.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.

Event Description

This report is being submitted as follow-up no.1 for mfg.Report no.9681834-2015-00205.

• Brand Name: CAPIOX FX25 HOLLOW FIBER OXYGENATOR AF
• Type of Device: OXYGENTOR
• 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: 5123057
• MDR Text Key: 27298797
• Report Number: 9681834-2015-00205
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Followup,Followup
• Report Date: 09/08/2015,10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CX*FX25RW
• Device Lot Number: 150413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/07/2015
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2015
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2015
• 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