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

Model Number 816571

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The reported issue was discovered when the fsr was troubleshooting the related complaint.Per fsr, he attempted to start the roller pump without tubing but the pump never started and would display an error message.These error messages were only displayed on the roller pump and did not have an audible alarm.A new pump was installed.The unit operated to the manufacturer's specifications.Data logs were returned to the manufacturer on 01-jun-2018.The suspect device was returned to the manufacturer for further evaluation.This complaint is related to (b)(4) / medwatch #: 1828100-2018-00318.

Event Description

It was reported that during the use of the device for a non-clinical activity, the roller pump would not start and displayed one of the following messages: 'pump jam', 'motor error', or 'service pump'.There was no patient involvement.

Manufacturer Narrative

The reported complaint was confirmed.The service repair technician (srt) was unable to duplicate the reported complaint.The unit 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.

Manufacturer Narrative

During laboratory analysis, the product surveillance technician (pst) could not confirmed the reported issue.The roller pump functioned normally throughout the evaluation.Per log analysis on (b)(6) 2018, each time the large roller pump was started it stops with a motor fault, or a belt slip jam status = true.The log confirms the complaint.

• 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
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORTATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7635670
• MDR Text Key: 112577149
• Report Number: 1828100-2018-00331
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)180203
• 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: 08/14/2018

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: 06/01/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2018
• Initial Date FDA Received: 06/25/2018
• Supplement Dates Manufacturer Received: 06/26/2018; 08/03/2018
• Supplement Dates FDA Received: 07/20/2018; 08/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2018
• 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