MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 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 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The cpg monitor is on a unit that is not used clinically.The fsr removed the cpg monitor and has returned it to the manufacturer for evaluation.The unit operated to the manufacturer¿s specifications.

Event Description

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the cardioplegia (cpg) monitor would not pass self-test.There was no patient involvement.

Manufacturer Narrative

If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

(b)(4).During laboratory analysis, the product surveillance technician (pst) powered on the monitor and the display illuminated but the monitor could not be calibrated.The cardioplegia (cpg) temperature readings would not read anything but 888 and the timers would not start.The pst temporarily replaced the computer board with a lab use computer board and the monitor then powered on normally with all functions of the monitor working properly.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6938725
• MDR Text Key: 90252008
• Report Number: 1828100-2017-00460
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2018

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: 09/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 10/16/2017; 08/16/2018
• Supplement Dates FDA Received: 11/10/2017; 08/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-06/14/12-017-C
• Patient Sequence Number: 1