FDA Adverse Event Other Summary report: N

ALARIS

MDR report key: 1781731 · Received July 22, 2010

Report

Report Number
MW5016873
Event Type
Other
Date Received
July 22, 2010
Date of Event
June 13, 2010
Report Date
July 22, 2010
Manufacturer
UNK
Product Code
FRN
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

A PT GOT A 100 FOLD OVERDOSE OF A VASO-ACTIVE DRUG, DUE IN PART TO SOME DESIGN ISSUES WITH THE PUMP. THE BASIC FACTS ARE, CHRONIC RENAL FAILURE PT IN HYPERTENSIVE CRISIS, DOCTOR ORDERED NITROGLYCERIN DRIP AT 5 MCG / MIN TO TRY TO CONTROL THE BP. EXPERIENCED NURSE SET UP THE DRIP, GETS A SCREEN TO CHOOSE MCG/KG/MIN VS MCG/MIN. BUT THERE IS A PARALLAX PROBLEM BECAUSE THE SCREEN IS RECESSED BUT THE BUTTONS ARE ON THE CASE, SO IF YOUR EYE IS ABOVE THE PUMP - TYPICAL, THEY ARE USUALLY MOUNTED ABOUT WAIST HEIGHT -, YOU COULD EASILY MISALIGN THE ARROW AND THE PROMPT AND PRESS THE WRONG ONE. WHICH IS WHAT HAPPENED, SHE INADVERTENTLY CHOSE MCG/KG/MIN WHEN SHE INTENDED TO CHOOSE MCG/MIN. -WE NEVER USE MCG/KG/MIN IN THE ED-. SHE THEN GOT A PROMPT FOR THE PT'S WEIGHT, ENTERED HIS WEIGHT -100 KG-, AND THEN THE DOSE OF 5. THE SCREEN HERE DOES SHOW MCG/KG/MIN, BUT OF COURSE SHE SAW WHAT SHE EXPECTED RATHER THAN WHAT WAS ACTUALLY DISPLAYED. IT THEN COMPLAINED THAT THE DOSE WAS HIGHER THAN THE LIBRARY UPPER LIMIT OF 3 MCG/KG/MIN, WHICH SHE OVER-RODE, BECAUSE WE ALWAYS START AT 5, AND THEN TYPICALLY GO UP RATHER RAPIDLY -EG, INCREASE BY 5 EVERY 5 MIN UNTIL GET TO AROUND 20 OR SO, OR UNTIL THE BP COMES DOWN-, AND THIS PT'S HYPERTENSION WAS QUITE SEVERE. SO, HE GOT 500 MCG/MIN INSTEAD OF 5. COMPLAINED OF A SEVERE HEADACHE, BUT SAID NITRO ALWAYS GIVES HIM HEADACHES. AFTER 15-20 MINS, WE NOTICED THE BAG WAS EMPTY, AND THEN RECONSTRUCTED THE ABOVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ALARIS ALARIS SMART PUMP FRN UNK DO NOT HAVE

Patients

Seq Age Sex Outcome Treatment
1 50 YR Other NONE RELEVANT