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

Model Number 801041

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during priming of the device for a cardiopulmonary bypass (cpb) procedure, the device failed to retain occlusion.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

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 (pst) observed the pump to retain occlusion and meet specifications throughout testing.The service repair technician (srt) found the pump to be within specification.The pump was adjusted to 0.0004 inch setting, ran overnight and remained at the 0.0004 inch setting.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.

• 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 CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: eileen dorsey ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 7037540
• MDR Text Key: 93327768
• Report Number: 1828100-2017-00525
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• 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: 11/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2004
• 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