FDA Adverse Event Malfunction Summary report: N

OUTLOOK 100

MDR report key: 1113463 · Received August 13, 2008

Report

Report Number: 1113463
Event Type: Malfunction
Date Received: August 13, 2008
Date of Event: August 13, 2008
Report Date: August 13, 2008
Manufacturer: B. BRAUN MEDICAL INC.
Product Code: FRN
Product Problem: Yes
Report Source: User Facility report
Reporter Location: CO, US

Narratives

Description of Event or Problem · 1

THIS REPORT IS AN UPDATE REGARDING THE ONGOING ISSUES WE CONTINUE TO HAVE WITH OUR B.BRAUN OUTLOOK 100 PUMPS. WE HAVE HAD AN ADDITIONAL 31 PUMPS (FOR A NEW TOTAL OF 274 PUMPS) "LOSE" THEIR DRUG LIBRARIES. THE PUMPS SIMPLY DEFAULT TO THEIR FACTORY PRESET AND PROMPT THE USER TO MANUALLY SET DOSING, ETC. INITIALLY THE MANUFACTURER HAD PROVIDED US WITH SOFTWARE UPGRADES, WHICH DID NOT SOLVE THE ISSUE. THEY THEN PROVIDED OUR FACILITY WITH 45 NEW BATTERIES, WHICH ONCE INSTALLED, DID APPEAR TO HELP SOLVE THE ISSUES. HOWEVER, WE HAVE NOW HAD THREE PUMPS LOSE THE LIBRARY AFTER THE NEW BATTERY INSTALL. THE MANUFACTURER STATES THEY ARE WORKING ON ANOTHER SOFTWARE UPGRADE. TO CLARIFY THE VOLUME/EXTENT OF THIS PROBLEM, IT SHOULD BE NOTED OUR PARTICULAR FACILITY HAS A TOTAL OF 440 PUMPS, OF WHICH 274 HAVE EXHIBITED PROBLEMS "LOSING" THEIR DRUG LIBRARIES. THIS REFLECTS MORE THAN HALF OF OUR INVENTORY. ADDITIONALLY, THE MANUFACTURER PROVIDED ONLY 45 NEW BATTERIES TO OUR FACILITY, WHICH COVERS LESS THAN 10% OF OUR PUMPS. OUR SISTER FACILITIES WITHIN OUR HEALTH SYSTEM REGION ALSO HAVE THESE PUMPS, AND HAVE EXPERIENCED SIMILAR ISSUES. 15 NEW BATTERIES WERE PROVIDED TO THESE OTHER FACILITIES. THERE ARE A TOTAL OF 700 PUMPS IN OUR HEALTH SYSTEM REGION (WHICH IS COMPRISED OF 11 FACILITIES, INCLUDING OUR OWN).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OUTLOOK 100	INFUSION PUMP	FRN	B. BRAUN MEDICAL INC.	13215	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	*