MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION H/S CUVETTE 1/2X1/2 BULK NS; BLOOD GAS MONITOR

Model Number 6922

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned and the lot number of the affected product was not provided; therefore, a complete investigation could not be performed and a root cause could not be determined.This event may be associated with a voluntary safety alert submitted by terumo on december 8, 2015.The safety alert number is 1124841-12/08/2015-004-c.(b)(4).Method: no testing methods performed.Results: no results available since no evaluation performed.Conclusions: unable to confirm complaint; device not returned.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, there was an h/s cuvette disconnect.No patient involvement as this occurred during prime.Product was changed out.Procedure was completed successfully.

• Brand Name: H/S CUVETTE 1/2X1/2 BULK NS
• Type of Device: BLOOD GAS MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball rd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6094342
• MDR Text Key: 59739495
• Report Number: 1124841-2016-00397
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6922
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1124841-12/08/2015-004-C
• Patient Sequence Number: 1