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

Model Number 801041

Patient Problem No Information (3190)

Event Date 12/11/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to emdr #1828100-2016-00006.On (b)(6) 2015 the large roller pump reported many "5v supply voltage test failure" events.This will cause an alarm to sound, and a red "x" to appear on the pump icon.The 5v is supplied by the power manager through the network interface card (nic) and associated cables.There is no indication that other pumps were having the same issue.A review of the complaint database lists one related complaint (refer to emdr #1828100-2016-00006) since the date the error had occurred.The reported issue could not be duplicated during laboratory evaluation and the root cause remained unknown.

Event Description

During data log review by the investigator, there was a 5 volt (v) supply voltage test failure on the roller pump.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) could not duplicate the issue, but replaced the pump pod, cable and display cable as a precaution.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: TERUMO 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: 5758703
• MDR Text Key: 48619505
• Report Number: 1828100-2016-00469
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• 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: 801041
• Device Catalogue Number: 801041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/07/2016
• Initial Date FDA Received: 06/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2004
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 1828100-03/27/12-006-C
• Patient Sequence Number: 1