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 Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the cardio monitor did not show temperature values.The product was not changed out.The customer calibrated the temperature.There was no blood loss nor adverse consequences to the patient.No other details regarding the nature of this event were provided.Diligence attempts are still ongoing in obtaining the remaining surgery related questions.

Manufacturer Narrative

The field service representative (fsr) was unable to duplicate the problem.The fsr calibrated the temperatures.The unit operated to the 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.

Manufacturer Narrative

The reported complaint could not be confirmed.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

Additional information received indicating that the event occurred during set-up of the device for a cardiopulmonary bypass procedure (cpb).The surgical procedure was completed successfully without delay.Per clinical review: during set-up of the cpb circuit, it was discovered that the sarns 8000 cardioplegia monitor was not displaying temperature.The perfusionist moved the temperature probes to available probe positions of the arterial monitor and temperatures were displayed on that device.The case was completed successfully, without delay and without associated blood loss.There was no harm observed.According to the perfusionist, this occurred on february 10, 2017.

• 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: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6386972
• MDR Text Key: 69736913
• Report Number: 1828100-2017-00115
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2017

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2017; 05/30/2017
• 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