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 Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

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 (b)(4).

Event Description

The user facility report to terumo cardiovascular that during cardiopulmonary bypass, the safety valve did not suck blood at its usual pump flow.The flow rate was then increased, and after a while, the valve sucked blood.* no consequences or impact 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 july 28, 2017.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).Visual inspection was performed on the returned sample, during which dried blood was noted within the valve, but no anomalies were noted anywhere on the device.All ops valves undergo 100% leak testing in process to ensure proper functionality of each component.The returned sample was manually run through each of these tests to determine if the umbrellas were functioning properly and not allowing air to enter the valve.The returned sample was found to fail the negative pressure relief test.A retention sample from the same product code and lot number combination was run through the same leak tests and was found to pass each test with no issues.Damage to the negative pressure relief valve may have occurred at some point have leak test, however, it is not possible to determine root cause.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 did not function properly as the negative pressure relief was not activated within specification.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 CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6749877
• MDR Text Key: 81248394
• Report Number: 1124841-2017-00159
• 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: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: LH130J
• Device Catalogue Number: N/A
• Device Lot Number: UF02
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• 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