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

Model Number LH130

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2015

Event Type  Injury  

Event Description

The user facility reported directly to the fda that while prepping perfusion tubing for a procedure, and not yet hooked up to a patient, the terumo h-130 one-way valve appeared to be faulty and caused a serious injury.The event was discovered by the manufacturer in the (b)(4) maude database review resulting in very limited available information.

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.Evaluation in progress.

Manufacturer Narrative

This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system.It was determined through information gathered by the user facility and distribution center, that the complaint related to this event was a duplicate of a previous complaint.This event had been previously reported and investigated through mfr # 1124841-2015-00173.The investigation and conclusion results reported in mfr # 1124841-2015-00173 have not changed due to this duplicate complaint.Terumo will be closing the duplicate complaint and all investigation results and conclusions for this report can be found in the original report for this event, in mfr # 1124841-2015-00173.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations- and as indicated by terumo cardiovascular system in the initial report submitted to the fda on 06/02/2015.A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusion code.All available information has been placed on file in quality management for appropriate tracking, trending and follow up.

Event Description

A voluntary medwatch report was received from the fda through which terumo was informed that the event required intervention of some kind.Details of this intervention were not provided.

• Brand Name: OVERPRESSURE SAFETY VALVE
• Type of Device: VALVE, O.P.S (STERILE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball rd.; elkton MD 21921
• Manufacturer Contact: robyn o'donnell ; 125 blue ball rd.; elkton, MD 21921 ; 8002623304
• MDR Report Key: 4817870
• MDR Text Key: 18002070
• Report Number: 1124841-2015-00181
• Device Sequence Number: 1
• Product Code: KFM
• 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: Other,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2015,09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LH130
• Device Lot Number: 209173478
• Other Device ID Number: (01)00699753450226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/23/2015
• Event Location: Hospital
• Date Manufacturer Received: 09/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other