MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RE

Device Problem Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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.(b)(4).Conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, there were issues removing the oxygenator from the holder.No patient involvement as this occurred after cardiopulmonary bypass.

Manufacturer Narrative

The sample was returned for evaluation.A review of the device history record revealed no anomalies.Visual inspection showed evidence that the neck was attempted to be removed from the oxygenator unit.These parts are not intended to be separated.During production, the neck is clamped onto the oxygenator as to ensure they don't separate during shipping, handling, or use.This complaint is not confirmed, as there is no product deficiency, this is a customer preference issue.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• 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: 5883489
• MDR Text Key: 52336945
• Report Number: 1124841-2016-00304
• 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,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: TN30
• Other Device ID Number: (01)00699753450103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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