MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Misassembled (1398)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

The sample was not provided for evaluation; however, a photo of the affected product was received from the customer.The photo showed the oxygenator and reservoir set up for a case, with the purge line connected to the reservoir lid.The one-way valve could be seen flowing in the direction towards the oxygenator, when the proper direction should be flowing towards the reservoir.The clamp was in the correct location on the purge line; therefore, the valve was built into the line in the wrong direction.A retention sample from the same product code/lot number combination was visually inspected and it was confirmed that the one-way valve was built in the proper direction on the purge line.(b)(4).Method: device from reserve sample evaluated; photographic inspection; manufacturing review.Results: assembly problem.Conclusions: maintenance deficiency.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 one way valve in purge line was backward.No patient involvement as this occurred during prime.Product was changed out.Procedure was completed successfully.

• Brand Name: STERILE FX15RWC W/ 3L RES
• 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: 6463525
• MDR Text Key: 72178827
• Report Number: 1124841-2017-00053
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: TP14
• Other Device ID Number: (01)00699753450783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2015
• 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