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

Model Number 16414

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the monitor would intermittently shut off and immediately turn back on.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) was unable to duplicate the shutdown of the monitor.The bus cable was replaced as a precaution.The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) installed the returned cable into a lab use cardioplegia (cpg) monitor.The pst operated the cpg monitor for three days with no failure of the monitor to power on and no loss of power occurred.He flexed the cable during operation of the monitor but that did not cause failure.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: ALARM, 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: 7086452
• MDR Text Key: 94989601
• Report Number: 1828100-2017-00548
• Device Sequence Number: 1
• Product Code: DSJ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2011
• 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