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

Model Number 16414

Device Problem Pressure Problem (3012)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

The fsr was unable to complete pressure testing because of the reported issue.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, pressure channel "b" on the cardioplegia monitor was not working.There was no patient involvement.

Manufacturer Narrative

Updated blocks: d10 and h6.The reported complaint was confirmed.The field service representative (fsr) verified the issue.He replaced the cardioplegia (cpg) printed circuit board (pcb).The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) observed the cpg monitor pressure channel b to function as intended.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: 8497412
• MDR Text Key: 141462353
• Report Number: 1828100-2019-00178
• 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: 07/22/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1