MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO PERFUSION SYSTEM 8000; 8K (PUMP, ROLLER TYPE)

Model Number 16402

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump stopped.The perfusionist (ccp) was not sure if it stopped on its own or if an alarm caused it to stop.This pump was being used as a sucker pump.The device was not changed out.The surgical procedure was completed successfully.There were no delays, no blood loss, and no adverse consequences to the patient.Per clinical review on (b)(6) 2014: the ccp stated this complaint actually occurred two to three weeks ago.The ccp could not remember the exact date.She stated that during cpb, the cardiovascular surgeon made the comment that the pump sucker was not working well.The ccp reached over to the sucker roller pump to increase the pump speed and noticed the pump had stopped.There was no message displayed on the pump.The ccp touched the forward switches on the pump and was able to re-start the pump.This behavior occurred two to three more times during the case with no warning or messages, and the pump was able to be restarted and used each time.The ccp did not notice any noisy operation or any other functional issues.The pump was removed from the base, after the procedure.The case was completed successfully, without delay, and without associated blood loss.There was no harm observed or reported.

Manufacturer Narrative

The field service representative (fsr) was unable to duplicate the problem reported.The fsr performed preventive maintenance (pm) on the roller pump and the roller pump passed inspection.The fsr checked cabling on base and didn't find anything out of the ordinary.

• Brand Name: TERUMO PERFUSION SYSTEM 8000
• Type of Device: 8K (PUMP, ROLLER TYPE)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEM CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4189363
• MDR Text Key: 5158568
• Report Number: 1828100-2014-00864
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953901
• 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: 09/25/2014

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: 16402
• Device Catalogue Number: 16402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2014
• Initial Date FDA Received: 10/16/2014
• Was Device Evaluated by Manufacturer?: No
• 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