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 801041

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The display failure was duplicated by the subsidiary service associate.

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the roller pump display failed and the pump icon displayed "?".As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no blood loss, nor adverse consequences to the patient reported.

Manufacturer Narrative

The complaint was duplicated as per laboratory evaluation.The product surveillance technician (pst) observed that the customer¿s display assembly had missing graphics.The pst replaced the customer graphics driver board with lab use only (luo) graphics driver board and this restored the functionality of the display assembly determining that the customer graphics driver board is defective.Per log analysis: on (b)(6) 2016, a perfusion screen was opened at 8:15:12 am.At 8:18:26 the large roller pump (arterial) rebooted.There was no indication why it rebooted.When this occurred the display will be off and a '?' will appear on the pump icon as reported.The perfusion screen was exited at 8:20:26 am and the system was power cycled.Another perfusion screen was opened at 8:22:38 am but the arterial pump was not present.The system was power cycled again and a perfusion screen was opened at 8:27:08 am.The arterial pump did not show up until 8:28:10 am.The arterial pump seemed to be losing power intermittently which caused the reported symptoms.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Manufacturer Narrative

The reported complaint was confirmed.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

There was no delay in the surgical procedure.

Manufacturer Narrative

The complaint was not duplicated during laboratory analysis.During laboratory evaluation, the product surveillance technician (pst) observed no (?) over pump icon indicating proper communication and power was being applied to the customer pump.

Manufacturer Narrative

The service repair technician (srt) did not perform functional test to customer pump due to partial pump disassembly during laboratory analysis.The pump pod was replaced as the most likely cause of the complaint.The pump operated to the manufacturer's specifications.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: 6215594
• MDR Text Key: 63837619
• Report Number: 1828100-2016-00835
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/28/2017

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: Health Professional
• Device Model Number: 801041
• Device Catalogue Number: 801041
• 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: 12/16/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 08/03/2017
• Supplement Dates FDA Received: 02/10/2017; 04/24/2017; 05/26/2017; 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2004
• 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