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

Model Number 816571

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service representative (fsr) could not duplicate the reported issue.The drive belt was replaced as requested by the customer.

Event Description

It was reported that during preventive maintenance the customer noticed that there was a beltslip but no error and alarm were observed.There was no patient involvement.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

The reported complaint was not confirmed.During laboratory analysis, the product surveillance technician installed the suspect belt in lab use only (luo) 6¿ pump and observed it to have normal operation when at optimal occlusion.An ¿underspeed¿ message began to appear on pump display only when pump occlusion was adjusted to 90 clicks past optimal occlusion.The pst tested pump for belt slip error condition with pump jam test fixture and observed pump to generate expected results.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 FOR ADVANC
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7347416074
• MDR Report Key: 6215527
• MDR Text Key: 63823083
• Report Number: 1828100-2016-00833
• 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,Followup
• Report Date: 04/06/2017

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: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/08/2017; 04/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2009
• 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