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

Model Number 16414

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00135.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the readings were not coming up at all on the cardioplegia (cpg) monitor.The device was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(4) 2016: according to the perfusionist (ccp), during set-up of the equipment, he noticed that no readings would show up on his cardioplegia (cpg) monitor.The ccp said that he did not need the cpg monitor for the case.They use quest microplegia units and use the 8k cpg monitor infrequently and only as needed.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

Updated blocks in report.(b)(4).A second part was received by the manufacturer on 21-mar-2016 for evaluation.The field service representative (fsr) verified the reported issue.After restarting and testing for an hour, he was unable to duplicate the issue.The fsr replaced the display assembly and power interface board, but the issue still existed.The fsr returned and installed a loaner cardioplegia (cpg) monitor.The unit operated to manufacturer specifications and was returned to clinical use.The suspect device and parts were returned to the manufacturer for further evaluation.

Manufacturer Narrative

The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) applied power to the returned cardioplegia monitor.The display and all functions operated as designed.After approximately two hours of operating, the display stopped illuminating.He temporarily replaced the temperature/pressure board, and after approximately two hours of operating, the display stopped illuminating as before.He temporarily replaced the power board, and after approximately two hours of operating, the display stopped illuminating as before.He temporarily replaced the computer board, and after four hours of operation, the monitor¿s display was still illuminated.The pst installed the returned display board, into the lab use only cardioplegia monitor and operated the monitor for seven hours with no loss of display occurring.Replacing the computer board ceased the loss of display illumination.The product will be sent to service to be brought to manufacturers 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 CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5473794
• MDR Text Key: 39757881
• Report Number: 1828100-2016-00134
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• 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: 03/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2011
• 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