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

Model Number 801041

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00149.During the laboratory evaluation, the product surveillance technician (pst) initiated rotation of the roller pump with no tubing installed.No problem was found as the device operated through entire speed range.The pst performed jam testing and the roller pump passes by correctly displaying "pump jam." he repeated jam testing multiple times and occasionally got ¿underspeed¿ prior to ¿pump jam,¿ this is typical.No problem found.The pst began rotation at optimal occlusion (speed not recorded).After approx.1 hour, a ¿beltslip¿ error message was seen briefly on the local display.It's possible the likely cause of this issue.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a follow-up emdr will be filed accordingly.

Event Description

The service repair technician (srt) reported that during routine testing of the device at the service center, a "pump jam" error intermittently activates with no load on the roller pump.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.Service records show the bearing has not been replaced since initial manufacture, indicating the pump still had the generation 1 bearing.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: 6 INCH ROLLER PUMP FOR ADVANCED PERFUSION SYSTEM 1
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
• 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: 5480989
• MDR Text Key: 39931219
• Report Number: 1828100-2016-00150
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131618
• 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: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-05/04/12-010-C
• Patient Sequence Number: 1