MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. 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 Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the ccp regarding the reported issue, the pressure alarms never went off which were set at 350 millimeter of mercury (mmhg) and intervention set at 450 mmhg.The field service representative (fsr) was unable to duplicate the reported issue.The fsr operated the cpg monitor and roller pump attached to cpg stop cable for approximately 30 minutes, starting and stopping clock, but was unable to get the monitor to shut down.Corrective maintenance/inspection was completed successfully.The unit operated to manufacturer specifications and was returned to clinical use.No part will be returned to the manufacturer for evaluation.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the cardioplegia (cpg) monitor randomly turned off and then immediately turned back on (acted like a power failure).All connections were secure and after turning back on, it needed to be re-calibrated and all previous numbers were erased.The customer also claimed that it happened once prior to case and then twice during case.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)(6) 2016: according to the perfusionist (ccp), during cpb, the cpg monitor randomly turned off and then immediately turned back on (reset), almost like there was a power failure.This occurred twice during bypass and reset within five seconds.The reset did not ever occur during active cpg delivery, so there was no impact to the patient.Proper function of the cpg monitor returned immediately when the device turned back on.The monitor required recalibration after the reset.The only alarm noted was the sound of the cpg monitor turning back on, no alarms prior to shutting off.The cpg pump was linked to the cpg monitor and had to be put back into forward flow position following the reset.The ccp checked all the cable connections to ensure they were secure and the circuit breaker on the back of the monitor with no problems noted.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.Later on (b)(6) 2016, the field service representative (fsr) reported that there was a note on the cardioplegia monitor stating that it was randomly powering itself off and on and resetting itself.The fsr performed troubleshooting on the unit and again was unable to duplicate the problem reported for the second time.The fsr sent the monitor to the manufacturer for evaluation and repair.During the laboratory evaluation, the reported complaint was duplicated.The cause of failure was determined to be the internal ampro central processing unit (cpu) board.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: 5633675
• MDR Text Key: 44909513
• Report Number: 1828100-2016-00307
• 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
• Report Date: 07/14/2016

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: Health Professional
• Device Model Number: 16414
• Device Catalogue Number: 16414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2011
• 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