FDA Adverse Event Malfunction Summary report: N

ALARIS SYSTEM

MDR report key: 23345673 · Received October 21, 2025

Report

Report Number: 2016493-2025-124731
Event Type: Malfunction
Date Received: October 21, 2025
Date of Event: August 12, 2025
Report Date: October 6, 2025
Manufacturer: CAREFUSION SD
Product Code: FRN
PMA / PMN Number: K133532
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

ROOT CAUSE: THE ROOT CAUSE FOR THE REPORTED ISSUE THAT DEVICE HAD OVER INFUSION - FREE FLOW WAS NOT DETERMINED BECAUSE NO PRODUCT OR DEVICE LOGS WERE RETURNED. PER 803.52(F)(11)(III). THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER.

Description of Event or Problem · 0

A COPY OF THE MEDWATCH REPORT FROM FDA WAS RECEIVED, WHICH STATES "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. 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.". THERE WAS PATIENT INVOLVEMENT BUT NO HARM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2452732	ALARIS SYSTEM	PUMP, INFUSION	FRN	CAREFUSION SD	8100

Patients

Seq	Age	Sex	Outcome	Treatment
1	1 DA	Male		8015