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 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the arterial monitor reportedly blanked out, then came back on by itself during surgery.The device was not changed out, as the monitor came back on right away and they kept using it for the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical summary on (b)(6) 2015: the arterial monitor reset very quickly during cpb and disrupted pressure measurement of the cpb circuit for a short time.The display returned quickly and the user would have needed to re-zero the pressure transducer to return pressure measurement and allow for high pressure limitation.The case completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

(b)(4).The field service representative (fsr) could not duplicate the reported issue.The fsr installed a loaner arterial monitor and tested successfully.The unit operated to manufacturer specifications and was returned to clinical use.The suspect device was returned to the manufacturer for further evaluation.

Manufacturer Narrative

The reported complaint was not confirmed.During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint.Testing included visual inspection, bench testing, mechanical agitation of external cables, cold soak testing, internal inspection, mechanical agitation of internal subassemblies, and heat testing.Close visual inspection of individual boards was performed (removed from enclosure for access to the entire board).The device was reassembled then further tested.In all cases, the complaint effects were not able to be duplicated.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 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: jan winder ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 5314179
• MDR Text Key: 34602424
• Report Number: 1828100-2015-01044
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2003
• 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