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 816571

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Per the user facility's perfusionist, the error messages happened while the pump was being used in the cardioplegia position using a 8:1 tubing set.

Event Description

It was reported that prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the user reported a belt slip and underspeed error.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

The field service representative (fsr) was unable to verify the belt slip.He replaced the pump.The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) observed no pump belt slip or underspeed error messages when tested per known perfusionist technique.

Manufacturer Narrative

Updated block: the reported complaint could not be confirmed.The service repair technician (srt) was not able to observe belt slip or underspeed error messages.The belt was replaced 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: 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
• MDR Report Key: 8348506
• MDR Text Key: 138423925
• Report Number: 1828100-2019-00083
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 00886799001370
• UDI-Public: (01)00886799001370(11)180120
• Combination Product (y/n): N
• PMA/PMN Number: K131618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 816571
• Device Catalogue Number: 816571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1