FDA Adverse Event Malfunction Summary report: N

SYNCHROMED II

MDR report key: 2921017 · Received January 17, 2013

Report

Report Number: 3004209178-2013-00732
Event Type: Malfunction
Date Received: January 17, 2013
Report Date: December 26, 2012
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 PRODUCTS: PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT'S HEALTHCARE PROVIDER (HCP) HAD AN ISSUE WITH REGARDS TO THE PUMP ALARM. THE HCP STATED SHE UPDATED THE PUMP TO REFLECT A DOSE INCREASE, BUT SHE DID NOT REFILL THE PUMP ON THAT DAY. THE PUMP INDICATED THAT THE REFILL DATE WAS THAT DAY AND THAT 10.3 ML 'HAD DISPENSED.' THE HCP STATED THAT SHE DID CHANGE THE RESERVOIR VOLUME AND THEN CHANGED IT BACK PRIOR TO UPDATING THE PUMP. TROUBLESHOOTING INDICATED THAT THE CHANGE IN VOLUME HAD TRIGGERED THE EMPTY RESERVOIR ALARM. TO RESOLVE THE ISSUE IT WAS RECOMMENDED THAT THE PUMP BE UPDATED TO FULL RESERVOIR AND THEN UPDATED A SECOND TIME WITH THE CORRECT RESERVOIR VOLUME. THE PATIENT WAS NOTED TO NOT HAVE HAD ANY SYMPTOMS AND WAS RECEIVING EFFECTIVE THERAPY. THE MEDICATIONS USED WITHIN THE SYSTEM WERE DILAUDID AND BUPIVACAINE. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26160	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1