MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP

Model Number 801041

Device Problems Leak/Splash (1354); Pumping Stopped (1503)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Per the manufacturer's subsidiary, the belt looses friction and just spins on the shaft stopping the pump.This is a demonstration unit only and not used clinically.

Event Description

It was reported that during routine testing of the device at the manufacturing engineering center (mec), grease had leaked from the bearing and the pump stopped.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Multiple diligence attempts by the manufacturer were unsuccessful in obtaining the part for evaluation.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: LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 7369959
• MDR Text Key: 103568277
• Report Number: 1828100-2018-00151
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

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: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/26/2018
• Supplement Dates Manufacturer Received: 04/27/2018
• Supplement Dates FDA Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1