SYNCHROMED II

MDR report key: 3813146 · Received May 15, 2014

Report

Report Number: 3004209178-2014-09034
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 3, 2014
Report Date: April 22, 2014
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2014-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT AN ALARM WAS NOT HEARD BUT CONFIRMED BY TELEMETRY. IT WAS NOTED THAT TELEMETRY CONFIRMS A CRITICAL ALARM DUE TO A MOTOR STALL. IT WAS REPORTED THAT INTERROGATION OF THE PUMP SHOWED A MOTOR STALL OCCURRENCE AND TUBE SET MESSAGE. IT WAS NOTED THAT THE PUMP WAS RE-INTERROGATED AND LOGS SHOWED A MOTOR STALL RECOVERY OCCURRENCE (B)(6) 2014 AT 09:45, THE SAME DATE AND TIME THE PUMP WAS INITIALLY INTERROGATED. IT WAS REPORTED THAT MOTOR STALL OCCURRED (B)(6) 2014 AT 18:15 AND STOPPED PUMP PERIOD MAY EXCEED TUBE OCCURRED (B)(6) 2014 AT 18:15. IT WAS NOTED THAT THE PATIENT HAD A MRI ON (B)(6) 2014 AND WAS IN THE HOSPITAL AND DID NOT HAVE THE PUMP STATUS CHECKED POST MRI. IT WAS REPORTED THAT THE PUMP WAS NOT ACTIVELY ALARMING AND THE PATIENT WAS HAVING NO THERAPY ISSUES AT THE TIME OF REPORT. IT WAS NOTED THAT THE PUMP WAS USED TO INFUSE PRIALT. IT WAS LATER REPORTED THAT NO OTHER TROUBLESHOOTING OR ACTION WAS TAKEN AFTER THE MOTOR STALL RECOVERY MESSAGE APPEARED. IT WAS NOTED THAT THE PATIENT DID NOT REPORT ANY SYMPTOMS. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE AT THE TIME OF REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290898	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00043 YR