FDA Adverse Event Injury Summary report: N

ALARIS SYSTEM PUMP MODULE

MDR report key: 880384 · Received July 12, 2007

Report

Report Number
2016493-2007-00030
Event Type
Injury
Date Received
July 12, 2007
Date of Event
June 7, 2007
Report Date
June 12, 2007
Manufacturer
CARDINAL HEALTH ALARIS PRODUCTS
Product Code
FRN
PMA / PMN Number
K012383
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OR, US
Reporter Occupation
BIOMEDICAL ENGINEER

Narratives

Description of Event or Problem · 1

FACILITY BIOMED REPORTED AN OVERINFUSION OF INSULIN WITH PATIENT REQUIRING D-50 TO TREAT LOW BLOOD GLUCOSE. NURSE REPORTED SHE HUNG NEW BAG WITH NEW TUBING AND USED "RESTORE" FEATURE TO PROGRAM 4 UNITS/HR. ONE HOUR LATER AT 2215, USER NOTICED BAG WAS EMPTY, AND CONFIRMED WITH ANOTHER NURSE THAT PUMP SHOWED RATE OF 4 ML/HR ON SCREEN. BLOOD GLUCOSE WAS 124 IN THE HOUR PRIOR TO EVENT, DROPPED TO 87 IMMEDIATELY AFTER EVENT, THEN DOWN TO 56. GAVE TWO 25 ML DOSES OF D-50 AND SUBSEQUENT BLOOD GLUCOSE LEVELS ALL INCREASED. INSULIN RESUMED AT 0400 AT 4 ML (4 UNITS) /HR ON A DIFFERENT PUMP WITH NO FURTHER PATIENT SEQUELAE NOTED. LVP MODULE SEQUESTERED, BUT POC UNIT AND TUBING SET NOT SAVED. REPEATED ATTEMPTS MADE TO GATHER FURTHER CLINICAL INFORMATION ABOUT EVENT WERE UNSUCCESSFUL. NO INFORMATION AVAILABLE ABOUT VOLUME OF FLUID OR CONCENTRATION OF INSULIN IN THE BAG. AS THE POC UNIT EVENT LOG WITH DETAILS OF PROGRAMMING WAS UNAVAILABLE, THE LVP EVENT LOG WAS REVIEWED, BUT RATES DO NOT MATCH REPORT OF EVENT: RATE 6 ML/HR AT 1840, DECREASED TO 5 ML/HR AT 2009, 3 ML/HR AT 2022, 5 ML/HR AT 2023, 3 ML/HR THEN IMMEDIATELY 5 ML/HR AT 2223, 3 ML/HR AT 2323. THERE IS NO EVIDENCE IN THE LOG OF ANY RATE OF 4 ML/HR DURING THE REPORTED TIME OF THE EVENT. REQUESTED THAT DEVICE BE SENT IN FOR FUNCTIONAL EVALUATION, BUT BIOMED REPORTED THAT WHEN HE LOOKED FOR IT, HE FOUND IT HAD BEEN PUT BACK INTO CIRCULATION AND HE HAS NO WAY TO FIND IT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ALARIS SYSTEM PUMP MODULE FRN, INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

Patients

Seq Age Sex Outcome Treatment
1 YR Required Intervention