MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS-SARNS 8000

Model Number 16413

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative was unable to duplicate the reported issue.The unit operated to manufacturer's specifications.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 before use of the device for a cardiopulmonary bypass (cpb) procedure, the display for arterial pressure was not showing any information.The other displays in the monitor were normal.The perfusionist replaced the arterial pressure cable and the arterial pressure transducer and still had the problem.The customer used the cardioplegia monitor channel b in place of the arterial pressure for the case and removed the unit from service.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was not confirmed.The field service representative (fsr) replaced power manager board in safety monitor as precaution.This board supplies power to arterial monitor and may have intermittent problem.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

During laboratory analysis, the product surveillance technician (pst) connected the monitor to power supply and connected a pressure simulator to the input of the monitor and the monitor operated for eight hours with no failure of the monitor.The pst soaked the monitor at 10°c for three hours and when removed it displayed pressure.The pst operated the monitor for 72 hours with no failure on the monitor to display pressure.The pst agitated the internal connections and circuit boards with no failure of the monitor to display pressure.

• Brand Name: SARNS 8000 PERFUSION SYSTEM
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS-SARNS 8000
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6575317
• MDR Text Key: 75610826
• Report Number: 1828100-2017-00242
• Device Sequence Number: 1
• Product Code: DTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K915183
• 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,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16413
• Device Catalogue Number: 16413
• Other Device ID Number: GTIN (01)00886799000205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/1994
• 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