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

Model Number LN130B

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was performed on the actual sample upon receipt, during which no anomalies were noted.The actual sample was pressure and flow tested by pressurizing with air and submerging the sample into a water bath.The unit was found to fail the forward flow test, not allowing flow through the duckbill valve within the device.Further inspection found that the duckbill valve would not open when under pressures within product specification.The device was then overpressurized above the product specification range until flow was finally initiated.After flow was able to be achieved, the duckbill opened within product specification.Although additional evaluation of this failure mode is being performed, it is currently believed to be a result of a process change at the duckbill supplier.(b)(4).

Event Description

The user facility reported to terumo cardiovascular systems corporation that prior to cardiopulmonary bypass, during prime, the overpressure safety valve was closed, or sealed shut.This occurred a total of three times.This event was initially deemed not reportable on december 1, 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 patient involvement as this occurred during prime.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 BULK, N-S
• 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: 6715692
• MDR Text Key: 80129159
• Report Number: 1124841-2017-00138
• 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,health
• 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: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LN130B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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