MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 4000ML; BLOOD GAS OXYGENATOR

Model Number 3CX*RX15RW40

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, (b)(4).Conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during set up, it was discovered that the arterial thermister was broken.No patient involvement as this occurred during set up.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

The sample was returned for evaluation.A review of the device history record revealed no manufacturing anomalies.The returned sample was visually inspected.It was found that the thermistor on the oxygenator was broken.The temperature strip within the thermistor kept the housing attached to the device; however, it was broken off of the port, which still remained bonded to the oxygenator.A retention sample from the same product code/lot number combination was visually inspected and confirmed to have no damages.All capiox units are 100% visually inspected at several points in the production process.It is likely that the thermistor was damaged by a shock force at some point during the handling of the product; however, when or how this shock force was applied was not able to be determined.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: HOLLOW FIBER OXY WITH 4000ML
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: shari bailey ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6004657
• MDR Text Key: 56812461
• Report Number: 1124841-2016-00348
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 3CX*RX15RW40
• Device Catalogue Number: N/A
• Device Lot Number: UE04
• Other Device ID Number: (01)00699753450141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2016
• 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