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

Model Number 16414

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 01/02/2019

Event Type  malfunction  

Manufacturer Narrative

Per the fsr, the user facility does not use the pressure channel, so they do not want any repairs at this time.The rest of the monitor is working to the manufacturer's specifications.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the second pressure channel on the cardioplegia (cpg) monitor would not zero out nor display any readings.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.No additional testing was completed as the user facility did not want any repairs done.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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8272022
• MDR Text Key: 134732186
• Report Number: 1828100-2019-00041
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• PMA/PMN Number: K960916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

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: Other
• Device Model Number: 16414
• Device Catalogue Number: 16414
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 03/04/2019
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1