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

Model Number LH130J

Device Problem Suction Problem (2170)

Patient Problem Blood Loss (2597)

Event Date 05/29/2017

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

Event Description

The user facility report to terumo cardiovascular that during cardiopulmonary bypass, the safety valve did not suck blood in the differential pressure.There was a blood loss of 80ml.Product was 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 jul 11, 2017.(b)(4).Visual inspection was performed on the returned sample, during which it was found that the negative umbrella was not in its proper place, as it had been pushed almost completely into the housing port.The returned sample was found to leak from the negative umbrella because it was not seated properly in the housing.This would have caused the ops valve to not suction during the event as air was leaking past the negative umbrella rather than suctioning blood.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.These units are also 100% visually inspected both during the leak testing step and during packaging.A retention sample from the same product code/lot number combination was obtained.Visual inspection found no anomalies on the retention sample.It was then manually run through each of the five leak tests to determine if the umbrellas were functioning properly.The retention sample was found to pass all five leak tests.It is possible that the unit was subjected to damage at some point after final release causing the negative umbrella to not be seated properly.As this event occurred during cpb, and not prime, it is possible for the valve to have been hit during use causing the damage to the umbrella valve.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted.The investigation results and conclusions, previously reported, remain the same; however, after additional review of these results, it was determined that the failure mode was not related to the safety alert, (b)(4).The investigation found that the unit leaked from the negative umbrella as it was not seated in the house properly.This is not related to the duckbill not allowing flow through the valve; therefore, it has been determined that this event is not related to the safety alert, as it had been previously reported.

• Brand Name: VALVE, O.P.S (STERILE) FOR TC
• Type of Device: OVERPRESSURE SAFETY VALVE
• 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: 6700809
• MDR Text Key: 79906257
• Report Number: 1124841-2017-00133
• 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

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: LH130J
• Device Catalogue Number: N/A
• Device Lot Number: UG13
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• 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-C
• Patient Sequence Number: 1