MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 CARDIOPLEGIA MONITOR; COMPUTER, BLOOD-PRESSURE-SARNS 8000 CARDIOPLEGIA MONITOR

Model Number 16414

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue was discovered by the hospital biomedical engineer during preventative maintenance.There was no impact on the customer as they seldom use the pressure channels.The customer will troubleshoot the pressure stimulator for this issue.

Event Description

It was reported that during the use of the device for a non-clinical activity, the cardioplegia monitor was having problems.When the customer tried to zero the pressure transducer, the display went blank instead of going to zero.There was no patient involvement.

Manufacturer Narrative

The reported complaint was not verifiable.The customer does not use the pressure transducer on the cardioplegia monitor.No parts were returned to the manufacturer for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: SARNS 8000 CARDIOPLEGIA MONITOR
• Type of Device: COMPUTER, BLOOD-PRESSURE-SARNS 8000 CARDIOPLEGIA MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6536447
• MDR Text Key: 74310653
• Report Number: 1828100-2017-00209
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/25/2017

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: Health Professional
• Device Model Number: 16414
• Device Catalogue Number: 16414
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: 07/13/2017
• Supplement Dates FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2001
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1