SYNCHROMED II

Report

Report Number: 3004209178-2014-08781
Event Type: Injury
Date Received: May 9, 2014
Report Date: April 16, 2014
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER; PRODUCT ID 8596SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER; PRODUCT ID 8840, LOT # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS AT THEIR HEALTH CARE PROVIDER (HCP) CLINIC ON THE DATE OF THE REPORT FOR A DOSING CHANGE, AND AFTER DOING THAT, THE HCP FOUND THAT AT THE PATIENT¿S LAST REFILL ON (B)(6) 2014, THE DRUG CONCENTRATION HAD CHANGED FROM 2.5 MG/ML TO 5 MG/ML, BUT WAS NOT PROGRAMMED. THE HCP CONFIRMED WITH THE SESSION DATA REPORT FROM THE REFILL THAT A BRIDGE BOLUS WAS NOT PROGRAMMED AND THE ONLY CHANGE WAS TO THE RESERVOIR VOLUME. IT WAS DISCUSSED THAT BASED ON THE PROGRAMMING AT THE TIME OF THE REPORT AND THE ACTUAL DRUG CONCENTRATION IN THE PUMP THE PATIENT WAS RECEIVING A LARGER DOSE THAN ACTUALLY PRESCRIBED. IT WAS NOTED THAT THE PATIENT WAS "USED TO THE INCREASED DOSE." IT WAS ADVISED THAT THE DRUG CONCENTRATION BE CORRECTED BUT THAT THE BRIDGE BOLUS PROMPT COULD BE IGNORED AS THE OLD DRUG HAD ALREADY BEEN INFUSED. THE PUMP WAS BEING USED TO DELIVER DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
281424	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1	00045 YR		Other