FDA Adverse Event Malfunction Summary report: N

SIGMA SPECTRUM

MDR report key: 3925125 · Received July 3, 2014

Report

Report Number
3925125
Event Type
Malfunction
Date Received
July 3, 2014
Date of Event
June 24, 2014
Report Date
July 3, 2014
Manufacturer
BAXTER HEALTHCARE CORP
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

PUMPS KEPT READING UPSTREAM OCCLUSION AND AIR IN LINE WHEN THERE WAS NO AIR IN LINE, WHICH IN THE MEAN TIME WERE NOT DELIVERING VASOACTIVE DRIPS (EPI AND HETASTARCH). WHILE RN WAS TRYING TO TRANSFER EPI DRIP TO A NEW PUMP, THE BLUE SLIDE CLAMP ON THE SIGMA PUMP TUBING BROKE AND THE EPI TUBING WAS STUCK IN THE PUMP AND THE RN WAS UNABLE TO REMOVE THE DRIP. THE DRIP ADMINISTRATION WAS FURTHER DELAYED BECAUSE RN HAD TO GRAB AND REPRIME NEW TUBING AND PLACE AND REPROGRAM IN A NEW PUMP. PATIENT'S BLOOD PRESSURE DROPPED TO 40S/20S.THIS FACILITY HAS HAD MULTIPLE SIMILAR EVENTS WITH THIS PUMP. THE FACILITY HAS BEEN WORKING WITH THE MANUFACTURER DIRECTLY FOR ALMOST A YEAR BUT THE PROBLEMS CONTINUE ON A REGULAR AND CONSISTENT BASIS AND ACROSS MULTIPLE NURSING UNITS. INITIAL AND ADDITIONAL EDUCATION HAS BEEN PROVIDED TO STAFF. EXTRA RESOURCES, INCLUDING A CLINICAL STAFF MEMBER, HAVE BEEN ADDED IN AN EFFORT TO ADDRESS THE ISSUE, BUT THE PROBLEMS CONTINUE. THE FACILITY IS CONCERNED REGARDING THE DELAY IN THERAPY, WHICH SOMETIMES HAS RESULTED IN THE NEED FOR ADDITIONAL MEDICAL CARE FOR THE PATIENT. PATIENTS AND STAFF HAVE VERBALIZED FRUSTRATION WITH THE PUMP (PATIENTS ARE UPSET THAT THE PUMP ALARMS FREQUENTLY AND STAFF ARE CONCERNED THAT THEY ARE UNABLE TO DISTINGUISH BETWEEN A CRITICAL ALARM AND A NON-EMERGENCY ALARM BECAUSE THE ALARM TONES ARE IDENTICAL).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
391960 SIGMA SPECTRUM INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700 *
391961 SIGMA SPECTRUM INFUSION PUMP FRN BAXTER HEALTHCARE CORP * *
391962 CLEARLINK DUO-VENT IV FLUID ADMINISTRATION SET FPA BAXTER HEALTHCARE CORP * *

Patients

Seq Age Sex Outcome Treatment
1 9 YR