SYNCHROMED II

MDR report key: 3961832 · Received July 28, 2014

Report

Report Number: 3004209178-2014-13610
Event Type: Malfunction
Date Received: July 28, 2014
Date of Event: July 7, 2014
Report Date: July 7, 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: OH, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A VOLUME DISCREPANCY OCCURRED; THE ACTUAL RESIDUAL VOLUME (ARV) WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME (ERV). ON THE DATE OF THIS REPORT, THE HEALTH CARE PROVIDER (HCP) WAS PERFORMING A REFILL AND ASPIRATED YELLOW FLUID DURING THE REFILL. THE ARV HAD BEEN 8ML OF CLOUDY YELLOW FLUID WHILE THE ERV HAD BEEN 2.3ML. THE HCP CHANGED NEEDLES AND RE-ACCESSED AND DIDN¿T GET ANYTHING BACK. THE PUMP WAS REFILLED ON THE DATE OF THIS REPORT. IT WAS NOTED THEY WERE ¿USUALLY OFF BY MAYBE 3ML AT PREVIOUS REFILLS¿. IT WAS REPORTED THAT THE PATIENT WAS HAVING AN ¿UP AND DOWN FEVER FOR A COUPLE WEEKS¿. IT WAS NOTED THE HCP COULD SEND THE NEEDLE BACK FOR ANALYSIS; HOWEVER, IT WAS UNCLEAR IF IT WAS TO BE RETURNED AND THERE WERE NO ALLEGATIONS AGAINST THE NEEDLE. THE ORIGINAL NEEDLE USED TO ASPIRE THE 8ML OF FLUID WAS THE 1.5 INCH NEEDLE. THE HCP MADE A SECOND STICK WITH ANOTHER NEEDLE BUT WAS NOT ABLE TO ASPIRATE ANY FLUID. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. 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
439707	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1	00050 YR