MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 PERFUSION SYSTEM; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP

Model Number 16402

Device Problem Pre Or Post-Pumping Problem (1477)

Patient Problem No Patient Involvement (2645)

Event Date 01/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) verified the reported issue.The fsr replaced the roller pump membrane panel and the unit operated to manufacturer specifications and was returned to clinical use.The suspect part was returned to the manufacturer for further evaluation.

Event Description

After use of the device for a cardiopulmonary bypass procedure, the user reported the sucker roller pump would not go in reverse.The case was completed at this point.There were no reported adverse consequences to the patient.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.During the laboratory evaluation, the product surveillance technician (pst) installed the returned board onto an 8k pump test fixture, pressed the reverse buttons on the membrane switch and the test fixture pump did not go into reverse.The pst observed the reverse switches had residue on them causing no continuity across the switches when they were pressed.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: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS ROLLER PUMP
• 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: 5443914
• MDR Text Key: 38463287
• Report Number: 1828100-2016-00090
• Device Sequence Number: 1
• Product Code: DWB
• 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
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2006
• 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