MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR WEST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RW

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2016

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.For this reason, terumo references evaluation conclusion code (b)(4).

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, it was noted that there was a crack on the female luer port of the oxygenator.No patient involvement.Product was changed out.Procedure completed successfully.

Manufacturer Narrative

The returned sample was visually inspected.It was confirmed that there was a crack along the seam of the l-shaped connector in the sampling line.A review of the device history revealed no production related anomalies.Replication testing was performed on a retention sampling manifold line.The l-connector was over-tightened onto a port of the reservoir, which lead to the l-connector cracking along the part, in the same way as the returned sample.During setup of the circuit, the l connector had been overtightened, causing it to crack.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6052215
• MDR Text Key: 58252889
• Report Number: 1124841-2016-00362
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 3CX*RX25RW
• Device Catalogue Number: N/A
• Device Lot Number: UH11
• Other Device ID Number: (01)00699753450110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• 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