MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (ROLLER PUMP)

Model Number 801041

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, a "beltslip" error was displayed on the roller pump.The device was not changed out, as the customer continued to use the pump.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per the clinical review on (b)(6) 2014: during cpb, "beltslip" was displayed on the local interface of the suction roller pump.This occurred one time during the procedure.The user elected to loosen the occlusion of the roller pump as a mitigation.There were no functional issues of the pump associated with this incident.After the procedure, the roller pump was removed from service.The procedure was completed successfully, without delay and without associated blood loss.There was no harm observed.

Manufacturer Narrative

This complaint is related to mdr 1828100-2014-01059.Evaluation is in progress, but not yet concluded.The subsidiary's manufacturing engineer center (mec) could not duplicate the reported issue.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (ROLLER PUMP)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4349492
• MDR Text Key: 5204119
• Report Number: 1828100-2014-01058
• Device Sequence Number: 1
• Product Code: DTQ
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2014

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: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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