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 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

Both affected samples were returned for evaluation.Visual inspection was performed on both samples, during which no anomalies were noted on either device.A review of the device history records revealed no manufacturing issues.The actual samples were pressure and flow tested by pressurizing with air and submerging the samples into a water bath.One of the units was confirmed to properly allow forward flow within specification, as well as operate as intended for all other components within the device.The second unit was found to not allow forward flow within product specification.Slight overpressurization was required to open the duckbill valve within the unit and allow forward flow.All other functions of this unit were confirmed to meet 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 testing facility reported to terumo cardiovascular systems corporation that during a non-clinical activity, two overpressure safety valves failed to function properly.This event was initially deemed not reportable on (b)(6) 2015; however, terumo has issued a voluntary safety alert, 1124841-06/25/2017-001-c, on (b)(6) 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: 6715759
• MDR Text Key: 80124063
• Report Number: 1124841-2017-00139
• 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: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Expiration Date: 12/31/2017
• Device Model Number: LH130J
• Device Lot Number: TA19
• Other Device ID Number: (01)00699753450233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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