MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX RX05 OXYGENATOR WITH RESERVOIR

Catalog Number CX*RX05RE

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2014

Event Type  malfunction  

Event Description

The user facility reported outlet damage on the rx05 device.Follow up communication with the user facility reported the following information: (1) when taking the product out of the package it was noted that the rx05 oxygenator had a rough edge on the arterial blood outlet; and (2) there was no patient involvement.

Manufacturer Narrative

The actual device is available but has not been returned to the manufacturing facility and evaluation.A follow up report will be submitted when the investigation is complete.A review of the device history record and the product release decision control sheet confirmed there were no indications of product related problems for this lot number.A review of the complaint file confirmed that this lot number has not been reported previously.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).Device not returned.

Manufacturer Narrative

This report is being submitted as follow-up #1 for mfg.Report #9681834-2014-00326 to provide the return sample evaluation.The involved device was returned to the manufacturing facility for evaluation.Visual inspection confirmed the edge of the blood inlet port on the oxygenator module had been fallen inward.The tube attached to the blood outlet port was removed and the blood outlet port was macroscopically inspected.No visible anomaly, including a break or deformity was found.Simulation testing was conducted on current product samples.The blood inlet port with the cap applied to it was exposed to a pushing force by pushing it against a flat floor.The blood inlet port got deformed.A review of device history record and product release decision control sheet of the involved product/lot# combination confirmed that there was no indication of production related problems.A search of the complaint file did not find any report with the involved product/lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the available information, the appearance of the involved sample is most consistent with the device bing subjected to a pushing force on the blood inlet port due to some factor(s).When the device is packed in the unit box, the blood inlet port on the oxygenator module does not come into contact with the cushion material.From this it is most likely that the blood inlet port was exposed to a pushing force in the state of the actual sample not being packed in the unit-box.From the available information, however, it cannot be determined when and how the actual sample was subjected to the pushing force.There is no evidence that this event was related to a device defect or malfunction.Device labeling does address the potential for such an event in the instructions-for-use by statements such as: "inspect the device and package carefully.Do not use if the package and/or device is damaged, or if caps are not in place." all currently available information has been placed on file by quality assurance at the manufacturing facility for appropriate tacking, trending and follow-up.

Event Description

This report is being submitted as follow-up #1 for mfg.Report #9681834-2014-00326 to provide the returned sample evaluation results.

• Brand Name: CAPIOX RX05 OXYGENATOR WITH RESERVOIR
• Type of Device: OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4357218
• MDR Text Key: 5112234
• Report Number: 9681834-2014-00326
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K022115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/27/2014,12/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: CX*RX05RE
• Device Lot Number: 130523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/25/2014
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2014
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2013
• 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