MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION OVERPRESSURE SAFETY VALVE; VALVE, O.P.S BULK, N-S FOR TC

Model Number LN130BJ

Device Problem Suction Problem (2170)

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

Event Date 01/14/2015

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 revealed no production related anomalies.The actual sample was pressure and flow tested by pressurizing with air and submerging the sample into a water bath.The unit was confirmed to properly allow forward flow within specification.Four additional flow and leak tests were performed on the sample to challenge each component within the valve.All tests passed within product specification.The reported issue was not able to be confirmed and a definitive root cause was not able to be determined.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems corporation that after cardiopulmonary bypass they experienced difficulties in suctioning blood through the overpressure safety valve.The occlusion on the roller pump had no issues.This event was initially deemed not reportable on february 11, 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.Product was not changed out as the event occurred after completion of the surgery.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 BULK, N-S FOR TC
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; etlkon, MD 21921 ; 8002623304
• MDR Report Key: 6695075
• MDR Text Key: 79518767
• Report Number: 1124841-2017-00127
• 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 Health Care Professional
• 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: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: LN130BJ
• Device Lot Number: RF19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2014
• 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