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

Model Number LH130J

Device Problem Suction Problem (2170)

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

Event Date 09/07/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was performed on the actual sample upon receipt, during which no anomalies were found anywhere on the device.A review of the device history records revealed no manufacturing issues.The actual sample was pressure and flow tested by pressurizing with air and submerging the sample into a water bath.During the testing, the unit was found to leak from the negative umbrella.Upon further visual inspection, it was found that the negative umbrella was not seated properly within the housing.Ops valves are 100% leak tested in process; therefore, it is likely that the damage occurred to the device at some point after leak testing, during shipping or handling of the device, that caused the negative umbrella to be pushed into the housing not allowing it to function as intended.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems corporation that during cardiopulmonary bypass the overpressure safety valve would not allow blood to be suctioned properly.Only air was able to be suctioned through the valve.This event was initially deemed not reportable on november 19, 2015; however, terumo has issued a voluntary safety alert, 1124841-06/25/2017-001-c, on june 25, 2017.This event has become associated with the safety alert and has since become reportable.No known impact or consequence to patient.Unknown if the product was changed out.Surgery was completed successfully.

Manufacturer Narrative

(b)(4).The investigation results and conclusions, previously reported, remain the same.

Event Description

(b)(4).

• Brand Name: OVERPRESSURE SAFETY VALVE
• Type of Device: VALVE, O.P.S (STERILE) FOR TC
• 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 ; 8002623304
• MDR Report Key: 6697884
• MDR Text Key: 79894390
• Report Number: 1124841-2017-00132
• 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,distri
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: LH130J
• Device Lot Number: RM01
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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