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 Protective Measures Problem (3015)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The fsr replaced the damaged display and completed pm.The unit operated to manufacturer specifications and was returned to clinical use.The reported complaint was confirmed during the laboratory evaluation.The product surveillance technician (pst) installed the switch membrane on an 8k pump test fixture.Pressed the start buttons and rotated the speed knob to start rotations of the pump guts.When the stop button was pressed, the pump guts kept rotating.The stop button had no effect.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

The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the stop button was not working on the roller pump.There was no patient involvement.

Manufacturer Narrative

There was damage to the up arrow section of the membrane switch but the up arrow switch was functional.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: 5764524
• MDR Text Key: 48634791
• Report Number: 1828100-2016-00475
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

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: Other
• Device Model Number: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/1999
• 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