FDA Adverse Event Malfunction Summary report: N

SPECTRUM SIGMA

MDR report key: 3925052 · Received July 3, 2014

Report

Report Number
3925052
Event Type
Malfunction
Date Received
July 3, 2014
Date of Event
June 29, 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

UPON HANGING NEW BAG OF TPN FOR A TPN DEPENDENT PATIENT, SIGMA PUMP WAS READING "AIR IN LINE" WHEN THERE WAS NO AIR IN THE LINE. THE LINE WAS REPRIMED AND PUMP WAS STILL READING AIR IN LINE. RN CHANGED THE LINE TO 4 OTHER SIGMA PUMPS IN THE ROOM. ALL PUMPS WERE READING AIR IN LINE WHEN NO AIR WAS IN LINE. CHARGE RN TO BEDSIDE TO TRY TO RESOLVE PROBLEM AND HAD THE SAME PROBLEM WITH ALL THE PUMPS READING AIR IN LINE. AS A RESULT, THE PATIENT'S BLOOD SUGAR LEVEL DROPPED. FOUND NEW PUMP THAT WAS NOT READING AIR IN LINE AND RN WAS ABLE TO BEGIN INFUSING TPN.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
391978 SPECTRUM SIGMA INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700 *
391979 SPECTRUM SIGMA INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700 *
391980 SIGMA SPECTRUM INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700 *
391981 SIGMA SPECTRUM INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700 *
391982 SIGMA SPECTRUM INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700 *

Patients

Seq Age Sex Outcome Treatment
1 8 MO