MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VALVE, O.P.S (STERILE) FOR TC; OVERPRESSURE SAFETY VALVE

Model Number LH130J

Device Problem Suction Problem (2170)

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

Event Date 07/18/2017

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).Results: results pending completion of evaluation.Conclusions: conclusion not yet available in progress.

Event Description

The user facility report to terumo cardiovascular that during set up, the duckbill valve is defective.The safety valve was incorporated in the suction line and was used under the negative pressure at -40 mm hg as usual.When the vent suction test was performed before use, the suction was not sufficient, but the device was used without being replaced as the valve could suck blood and the procedure was successfully completed.(suction was not performed with holding the release valves.) no known impact or consequences to patient; product was not changed out; procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on aug 4, 2017.(b)(4).Visual inspection was performed on the returned sample, during which no anomalies were noted anywhere on the device.Ops valves are subject to a 100% leak test, which includes five different tests the units are run through to ensure there are no leaks and both the umbrellas and duckbills are functioning properly.Upon evaluation of the returned sample, it was found to function as intended, and met all of the product specifications.Based on the complaint description, the suction or flow through the ops valve was not sufficient.This is believed to be an issue with the forward flow through the duckbill valve.The reported issue was not able to be replicated; therefore, the complaint was not confirmed.The cause of the issue with the duckbill is due to a process change at the supplier, specifically during the washing/cleaning step; however, the investigation for this is ongoing.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

(b)(4).

• Brand Name: VALVE, O.P.S (STERILE) FOR TC
• Type of Device: OVERPRESSURE SAFETY VALVE
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6766665
• MDR Text Key: 81847126
• Report Number: 1124841-2017-00165
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K820297
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2017

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: 07/31/2018
• Device Model Number: LH130J
• Device Catalogue Number: N/A
• Device Lot Number: TL01
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 08/09/2017; 12/01/2017
• Supplement Dates FDA Received: 08/25/2017; 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1124841-06/25/2017-001-R
• Patient Sequence Number: 1