FDA Adverse Event Malfunction Summary report: N

TERUMO ADVANCED PERFUSION SYSTEM 1

MDR report key: 3896741 · Received May 19, 2014

Report

Report Number: 1828100-2014-00416
Event Type: Malfunction
Date Received: May 19, 2014
Date of Event: January 1, 2014
Report Date: April 25, 2014
Manufacturer: TERUMO CARDIOVASCULAR SYSTEMS CORP.
Product Code: DTQ
PMA / PMN Number: K022947
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED. THIS COMPLAINT IS RELATED TO THE FOLLOWING MDR #'S: 1828100-2014-00428, 1828100-2014-00427, 1828100-2014-00426, 18282100-2014-00424, 1828100-2014-00423, 1828100-2014-00422, 1828100-2014-00421, 1828100-2014-00420, 1828100-2014-00419, 1828100-2014-00418, 1828100-2014-00417. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE PUMP LIDS, TESTED THE PUMP OPERATION PERTAINING TO THE OCCLUSION AND PUMP LID OPERATION AND CONTROL OF THE ROLLER PUMP. THE SYSTEM OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE FSR DOWNLOADED THE DATA LOGS AND RETURNED THE SUSPECT LIDS TO THE MANUFACTURER FOR FURTHER EVALUATION.

Description of Event or Problem · 1

THE PERFUSIONIST (CCP) CALLED THE FIELD SERVICE REPRESENTATIVE (FSR) AND REPORTED THE PUMP LID WAS FALLING OFF THE ROLLER PUMP ON THE PERFUSION SYSTEM. THE DEVICE WAS NOT CHANGED OUT. THERE IS NO SPECIFIC DATE, TIME OR OCCURRENCES OF THE ISSUE WHICH CAN HAPPEN AT ANY TIME THE SYSTEM IS USED. THIS COMPLAINT HAS NO REPORTS OF ANY DELAY, OR IMPACT TO A CASE DUE TO THIS ISSUE. NO HARM HAS BEEN REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
296329	TERUMO ADVANCED PERFUSION SYSTEM 1	APS 1 (ROLLER PUMP)	DTQ	TERUMO CARDIOVASCULAR SYSTEMS CORP.	816570

Patients

Seq	Age	Sex	Outcome	Treatment
1