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 APS1

Model Number 801041

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This complaint is related to (b)(4) / medwatch #1828100-2017-00033 and medwatch #1828100-2017-00034.

Event Description

It was reported that during pre-cardiopulmonary bypass procedure, the pump stopped.A service error message was displayed on the screen.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss or adverse consequences to the patient.

Manufacturer Narrative

Evaluation is in progress, but not yet concluded.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) was not able to duplicate the complaint.The pst performed multiple tests and observed no pump stops, no decreasing flow, and no service pump error messages while operating pump at optimal occlusion settings.When pump was extremely over occluded with 1.4 software, loaded pump can randomly decrease the flow rate and produce service pump error messages.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 via data log analysis.Per data log analysis, only the pump log was provided.On (b)(6) 2016, a perfusion screen was opened at 10:13:42.The pump was started at 13:26:16 and stopped 3 times at 13:28:10, 13:30:14, and 13:30:41.There were no indication in the log to indicate why the pump stopped.The perfusion screen was exited at 13:30:48.The system was power cycled twice, each time opening a perfusion screen.There were several pump stopped but none associated with a trigger or error.There is no way to tell from the log if "service pump" was displayed.The service repair technician (srt) performed functional test and observed customer pump to operate as intended.Roller pump operated to the manufacturer's specification.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 APS1
• 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: 6277669
• MDR Text Key: 66007850
• Report Number: 1828100-2017-00032
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K022947
• 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
• Report Date: 06/28/2017

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?: Yes
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 01/25/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2017; 03/24/2017; 06/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2007
• 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