FDA Adverse Event Malfunction Summary report: N

SYNCHROMED II

MDR report key: 3895379 · Received June 25, 2014

Report

Report Number: 3004209178-2014-12066
Event Type: Malfunction
Date Received: June 25, 2014
Date of Event: June 5, 2014
Report Date: June 5, 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 MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 8 709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: CATHETER; PRODUCT ID 8598A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER; PRODUCT ID 8840, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED A PRIMING BOLUS WAS INCORRECTLY PERFORMED. IT WAS STATED 2CM WAS REMOVED FROM THE ORIGINAL PUMP SEGMENT. IT WAS NOTED THE MANUFACTURER'S REPRESENTATIVE (REP) THOUGHT IT SHOULD HAVE BEEN A 24CM SPINAL CATHETER INSTEAD OF A 19CM THAT WAS PROGRAMMED. IT WAS NOTED THE HEALTH CARE PROVIDER (HCP) TOLD THEM 19CM, BUT THEY THOUGHT THEY RECEIVED THAT INFORMATION FROM THE OLD CATHETER THAT WAS PROGRAMMED INTO THE PUMP. IT WAS REPORTED A PRIMING BOLUS OF .389ML WAS PROGRAMMED BUT IT SHOULD HAVE BEEN .250ML. IT WAS NOTED THE PRIMING BOLUS HAD BEEN COMPLETED. IT WAS NOTED THE PATIENT RECEIVED A 2.78MG BOLUS SINCE THE PRIME WAS PROGRAMMED AT .389ML. THE PUMP WAS USED TO DELIVER DILAUDID AT A CONCENTRATION OF 20MG/ML AND DOSE OF 10.9MG/DAY. ADDITIONAL INFORMATION REPORTED THE PATIENT WAS DOING FINE AND DID NOT HAVE ANY ADVERSE REACTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
370443	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00047 YR