FDA Adverse Event Malfunction Summary report: N

BAG INFUSOR 500CC

MDR report key: 2031659 · Received March 21, 2011

Report

Report Number
2031659
Event Type
Malfunction
Date Received
March 21, 2011
Date of Event
February 17, 2011
Report Date
March 21, 2011
Manufacturer
GE HEALTHCARE
Product Code
KZD
Product Problem
Yes
Report Source
User Facility report
Reporter Location
FL, US

Narratives

Description of Event or Problem · 1

THE INFUSOR BAG WAS NOTED TO BE LOSING PRESSURE CAUSING ARTERIAL LINE TO PARTIALLY FAIL. I WAS ABLE TO RETURN ARTERIAL LINE TO PROPER FUNCTION AFTER RE-INFLATING INFUSOR BAG. THE INFUSOR BAG WAS REMOVED AND REPLACED. I WAS INFORMED BY THE STAFF THAT THIS HAS OCCURRED TO SEVERAL PATIENTS RECENTLY. CENTRAL SUPPLY WAS NOTIFIED OF THE FAILURE OF THE PRODUCT. THERE WAS NO HARM TO THE PATIENT.===========REPORTER'S RESPONSE============THE REPORTER INDICATED THEY HAVE ABOUT 20 PATIENTS INVOLVED IN THIS INCIDENT. ANOTHER 10-20 PATIENTS THEY SUSPECT WERE INVOLVED ON PREVIOUS INCIDENTS. THE NUMBERS REFLECT NUMBER OF PATIENTS AT THEIR INSTITUTION AND NOT AT ANY OF THEIR DIVISIONS. THE REPORTER ALSO INDICATES THEY HAD SIMILAR EVENT MAYBE 5 YEARS AGO. "DURING THIS LATEST EPISODE WE HAD AT LEAST TWO PATIENTS LOSE THEIR ARTERIAL LINES BECAUSE THEY CLOTTED OFF SECONDARY TO THE INFUSION BAG DEFLATING AND THE SUBSEQUENT LOSS OF A CONTINUOUS INFUSION OF SALINE THROUGH THE ARTERIAL CATHETER. WE HAD SEVERAL OTHER ARTERIAL LINES LOSING FUNCTION (CLOTTING OF THE CATHETER SUSPECTED) DURING THIS TIME FRAME FOR "UNKNOWN" REASONS THAT MAY HAVE BEEN RELATED TO THE LOSS OF THE SALINE INFUSION BUT THERE WAS NOT DOCUMENTATION OF THE INFUSION BAGS BEING DEFLATED." THEY BELIEVE THE LOT NUMBER LISTED ON THIS REPORT IS THE ONLY LOT NUMBER INVOLVED IN THIS EVENT. "THE LEAKS APPEARED TO BE OCCURRING INTERNALLY IN THE STOP COCK. IF WE SEALED THE LUER LOCK CONNECTION AT THE STOP COCK WITH A DEAD END CAP THE LEAKS STOPPED. IF WE LEFT THE LUER LOCK CONNECTION OPEN AND HAD THE STOP COCK TURNED TO THE OFF POSITION (TOWARD BAG) WE LOST PRESSURE OVER A SPAN OF AN HOUR OR TWO."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BAG INFUSOR 500CC BAG INFUSOR 500CC KZD GE HEALTHCARE * 2740

Patients

Seq Age Sex Outcome Treatment
1 16 YR