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

Model Number 801041

Device Problems Low Audible Alarm (1016); Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the perfusionist (ccp) heard an audible alarm, but was not sure what it was for.He then saw that the orange capped roller pump (a sucker) had stopped.The device was not changed out, the ccp restarted the roller pump and normal operation resumed.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: according to the detailed info received from fsr and the info contained in the system logs, the ccp noticed that the large roller pump (labeled as sucker 1) stopped during the early minutes of cpb.According to the logs, it appears that cpb was initiated about 9:01 am.At about 9:09 am, there is an "underspeed" alert message posted for sucker 1 and followed shortly by an "overcurrent" event (pump jam).A roller pump is designed to stop when pump jam is experienced, and that is what occurred in this case.This pump recently had the new software 1.40 installed and this software is designed to redue the incidence of pump jam, but not eliminate this alert.Pump jam occurs in cases of extreme over-occlusion, crossed tubing in the pump, excessive tubing in the pump, or foreign debris in the pump.Pump jam conditions will allow for re-start one the causative condition (e.G.Over occlusion) is mitigated.In this case, the sucker 1 pump was able to be re-started in a reasonably quick fashion.After the case, the fsr detailed to the ccp the causes and design reasons for "underspeed" and pump jam.

Manufacturer Narrative

On 12/10/2014, the fsr had performed notice of field correction (nfc), (upgraded software in large roller pumps to version 1.40).On 12/12/2014, the fsr met with the ccp and tested the operation of the system-1.The fsr created air and level alarms so that the ccp could see and hear how these were configured for this system-1.The fsr looked at the data files and saw that at 12/11/2014; 09:08:53 an "underspeed" followed immediately by a "jam status" message was logged (the ccp confirmed that this was about the time when the audible alarm and roller pump stoppage occurred during the surgery).The fsr installed the same medtronic tubing that customer uses in the raceway and occluded the roller pump the whole way: the roller pump continued to rotate without any stoppage or alarms.Then the fsr used the "manufacturer pump jam test device" (the device that is used by the manufacturer's service during release testing), and created a pump jam.No parts will be returned to the manufacturer for further evaluation.

• 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: 4366120
• MDR Text Key: 21769751
• Report Number: 1828100-2014-01140
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2004
• 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
• Treatment: MEDTRONIC TUBING