FDA Adverse Event Malfunction Summary report: N

INFINITY ORANGE SMALL VOLUME

MDR report key: 2801105 · Received October 9, 2012

Report

Report Number
2801105
Event Type
Malfunction
Date Received
October 9, 2012
Date of Event
September 4, 2012
Report Date
October 9, 2012
Manufacturer
MOOG MEDICAL DEVICES GROUP (ZEVEX)
Product Code
LZH
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

PATIENT USES AN ENTERAL PUMP FOR CONTINUOUS FEEDINGS 22HR/DAY. MULTIPLE PUMPS HAVE BEEN DELIVERED TO PATIENT'S HOME WITH SAME COMPLAINT-NUMEROUS ALARMS FOR 'NO FOOD' WHEN THERE IS FOOD PRESENT IN BAG/TUBE. ALARMS OCCUR AT LEAST DAILY, OFTEN MULTIPLE TIMES/DAY. ANY ATTEMPT TO REMEDY ONLY LAST A SHORT TIME. THE MANUFACTURER OFFERS NO EXPLANATIONS AS TO WHY ALARMS OCCUR OTHER THAN TROUBLESHOOTING AS PRINTED IN THE HANDBOOK. ONLINE SEARCHES FOR SIMILAR COMPLAINTS LIST THE NEW BAG DESIGN AS RESPONSIBLE FOR THE PROBLEM. WITH PATIENT'S FEEDINGS, THE AIR IS PURGED BEFORE CONNECTING TO THE PUMP, BUT DURING THE FEEDING TINY AIR BUBBLES PASS THROUGH THE SENSOR AND ARE DETECTED CAUSING THE 'NO FOOD' ALARMS. NO LESS THAN 6 PUMPS HAVE BEEN DELIVERED SINCE JUNE OF THIS YEAR AND MANY MORE CALLS HAVE BEEN TAKEN BY STAFF TO MANAGE THIS PROBLEM WITH THE EQUIPMENT. THE PATIENT DID REQUIRE ADDITIONAL MEDICAL CARE DUE TO THE INTERRUPTED FEEDINGS. STAFF FEEL THE COMPANY NEEDS TO GO BACK TO FORMER DESIGN OR CREATE A NEW BAG DESIGN THAT DOES NOT CAUSE THESE PROBLEMS.THE FAMILY STATED THAT THEY HAVE TO 'TRICK' THE PUMP INTO WORKING. THEY HAVE TO PLACE A PAPER TOWEL IN FRONT OF THE SENSOR IN ORDER FOR THE ALARM TO QUIT INDICATING THAT THERE IS NO FOOD WHEN IN FACT THERE IS FOOD IN PLACE. STAFF DEFINITELY DOES NOT FEEL THAT 'TRICKING' THE MACHINE IS SAFE AND HAVE INSTRUCTED PARENTS NOT TO DO THIS.ACCORDING TO STAFF, THIS EVENT TYPE HAS OCCURRED ON MORE THAN ONE OCCASION WITH OTHER PATIENTS AND FAMILIES. HANDS-ON TRAINING IS PROVIDED TO FAMILIES PRIOR TO THE FAMILY USING THE EQUIPMENT. HANDOUTS ALONG WITH THE HANDBOOK ARE GIVEN TO STAFF AND FAMILIES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INFINITY ORANGE SMALL VOLUME PUMP, INFUSION, ENTERAL LZH MOOG MEDICAL DEVICES GROUP (ZEVEX) * CF1214604
2 INFINITY ORANGE TUBE, BAG, FEEDING LZH MOOG MEDICAL DEVICES GROUP (ZEVEX) * *

Patients

Seq Age Sex Outcome Treatment
1 7 MO