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

Model Number 3CX*RX25RW

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The actual device was not returned for evaluation; however a photograph of the event was provided by the user facility.Upon inspection of the provided photo, it was confirmed that the purge line was missing the small white clamp, and the line was being clamped off by hemostats.A retention sample from the same product code/lot number combination was visually inspected and confirmed to have the white clamp present on the purge line.As the clamp is assembled between the vernay valve and the l-shaped connector, it would have to be placed onto the line during the purge line assembly process.The likely cause of the clamp missing from the line is that it had not been properly placed onto the purge line during assembly.A review of the device history record revealed no production related anomalies.(b)(4).All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the roberts clamp was missing from the recirculation line.No known impact or consequence to patient.Product was not changed out.Procedure was completed successfully.

• Brand Name: CAPIOX RX25 OXYGENATOR WEST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6085795
• MDR Text Key: 59462275
• Report Number: 1124841-2016-00384
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UH25
• Other Device ID Number: (01)00699753450110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2016
• Initial Date FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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