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

Model Number LH130J

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was performed on the actual sample, during which no anomalies were noted.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.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 pressurized above the product specification range, and flow was achieved.A retention sample from the same product code and lot number combination was tested using the same methods, and was confirmed to function as intended.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 trading company reported to terumo cardiovascular systems corporation that during incoming inspection, a non-clinical activity, the ventilation of the overpressure safety valve was defective.This event was initially deemed not reportable on february 1, 2017; 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 a non-clinical event.

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: 6715872
• MDR Text Key: 80144745
• Report Number: 1124841-2017-00143
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Expiration Date: 03/31/2019
• Device Model Number: LH130J
• Device Lot Number: UE04
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/25/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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-R
• Patient Sequence Number: 1