FDA Adverse Event Malfunction Summary report: N

BD ALARIS CAREFUSION

MDR report key: 22883985 · Received August 25, 2025

Report

Report Number
MW5175179
Event Type
Malfunction
Date Received
August 25, 2025
Date of Event
August 12, 2025
Report Date
August 19, 2025
Manufacturer
BECTON, DICKINSON, AND COMPANY / CAREFUSION 303, INC.
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
501
Health Professional
Yes

Narratives

Description of Event or Problem · 0

AS PART OF THEIR WORKFLOW, THE ANESTHESIOLOGISTS SET UP, PROGRAMMED THE INFUSION, AND PAUSED IT PRIOR TO ATTACHING THE INTRA VENOUS LINE TO THE PATIENT. THEY REPORTED THAT WHEN THEY PRESSED THE PAUSE BUTTON, THE DRUG CONTINUED TO DRIP (FREE FLOW). "NO PATIENTS WERE AFFECTED*. FINDINGS RECENT LITERATURE AND AN FDA RECALL HIGHLIGHT CONCERNS REGARDING FREE FLOW EVENTS IN BD ALARIS¿ INFUSION PUMPS. AN ARTICLE FROM THE BRITISH JOURNAL OF ANESTHESIA (2025) DESCRIBES A NEAR MISS INVOLVING UNINTENDED FREE FLOW OF PROPOFOL DUE TO A MALFUNCTION WHILE THE PUMP WAS PAUSED, EMPHASIZING THE RISK OF PASSIVE FLOW WHEN THE TUBING IS NOT ADEQUATELY COMPRESSED. A 2006 STUDY IN ANESTHESIOLOGY REPORTS SIMILAR ISSUES WITH THE ALARIS 8100 PUMP, WHERE INCORRECT LOADING OF THE TUBING LED TO A FREE FLOW EVENT BECAUSE THE PUMP DOOR CLOSED IMPROPERLY, PREVENTING THE FLOW-STOP MECHANISM FROM FUNCTIONING. ADDITIONALLY, BD ISSUED A RECALL IN JULY 2025 FOR ALARIS AND BD ALARIS PUMP MODULES SERVICED WITH OUTDATED BEZEL KITS, WHICH COULD DEGRADE OVER TIME AND LEAD TO SERIOUS RISKS LIKE FREE FLOW. DETAILED LOG REVIEW IN OUR CASE SHOWED CORRECT PROGRAMMING BY THE END USER, WITH THE PAUSE COMMAND ACKNOWLEDGED AND EXECUTED; HOWEVER, THE SYSTEM FAILED TO FUNCTION AS EXPECTED, LEADING TO A DRUG FREE FLOW. COLLECTIVELY, THESE FINDINGS UNDERSCORE THE CRITICAL NEED FOR PROPER PUMP MAINTENANCE, CORRECT INTRA VENOUS SET LOADING, AND ENHANCED DESIGN FEATURES TO PREVENT SUCH INCIDENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2723242 BD ALARIS CAREFUSION PUMP, INFUSION FRN BECTON, DICKINSON, AND COMPANY / CAREFUSION 303, INC. 8015

Patients

Seq Age Sex Outcome Treatment
1 1 DA Male PUMP ACCESSORIES (TUBING, ETC.).