FDA Adverse Event Malfunction Summary report: N

SIGMA SPECTRUM

MDR report key: 3931197 · Received July 10, 2014

Report

Report Number
3931197
Event Type
Malfunction
Date Received
July 10, 2014
Date of Event
July 8, 2014
Report Date
July 10, 2014
Manufacturer
BAXTER HEALTHCARE CORP
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PUMP WAS ALARMING AND SYSTEM ERROR CODE 323 NOTED. UNABLE TO SUCCESSFULLY TROUBLESHOOT THE PROBLEM. UNKNOWN WHY PUMP WAS ALARMING: PREVIOUSLY FUNCTIONING WITHOUT DIFFICULTY.THIS FACILITY IS EXPERIENCING MULTIPLE SIMILAR ISSUES WITH THIS DEVICE (EG: 50+ ISSUES PER DAY FACILITY WIDE). THE PUMPS FREQUENTLY ALARM AND STAFF ARE UNABLE TO SUCCESSFULLY TROUBLESHOOT THE CAUSE. BIOMED HAS CHECKED THE PUMPS AND CANNOT DETERMINE THE CAUSE OF THE FREQUENT ALARMS. ALL OF THE PUMPS AT OUR FACILITY ARE AFFECTED (ESTIMATE >1,000). THERE IS NO WARNING OR PATTERN TO WHEN THE PUMPS ALARM. THERE IS NO PATTERN WITH THE TYPE OF FLUIDS INFUSING ON THE PUMPS WITH THE ALARMS: OCCURS WITH BLOOD/BLOOD PRODUCTS, TPN, IV FLUIDS/MEDICATIONS, ETC. WHEN THE ALARM SOUNDS, STAFF FIRST TRY TROUBLESHOOTING THE DEVICE ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. IF THIS DOES NOT WORK, STAFF HAVE TO GET ANOTHER IV PUMP, WHICH CAUSES A DELAY IN THERAPY TO THE PATIENT. THIS FACILITY HAS BEEN IN CONTACT WITH THE MANUFACTURER MULTIPLE TIMES OVER THE LAST SEVERAL MONTHS. THERE IS CURRENTLY NO SOLUTION TO THE PROBLEM THAT HAS WORKED. PUMPS THAT ARE FULLY CHARGED AND THAT HAVE NEW BATTERIES HAVE THE SAME PROBLEM. BIOMED HAS INVESTIGATED THE ISSUE AND CANNOT DETERMINE THE CAUSE. THE PUMP CLEANING PROCESS IS DONE ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS AND DOES NOT APPEAR TO BE A SOURCE OF THE PROBLEM. LIKEWISE, THE BATTERIES ON THE DEVICES ALSO HAVE BEEN CHANGED OUT FOR NEW BATTERIES, BUT THE ISSUE CONTINUES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
405338 SIGMA SPECTRUM INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700 *

Patients

Seq Age Sex Outcome Treatment
1 54 YR CARDIAC DRUGS