MAUDE Adverse Event Report: BD ALARIS/CAREFUSION 303, INC. BD ALARIS IV INFUSION PUMP; PUMP, INFUSION

Device Problems Excess Flow or Over-Infusion (1311); Obstruction of Flow (2423)

Patient Problem Weakness (2145)

Event Date 11/24/2020

Event Type  malfunction  

Event Description

Patient was on insulin drip in labor; insulin rate had been verified by 2 rn's at the beginning of administration with full bag of 100ml, medication had been scanned properly and pump programmed properly.Patient expressed to rn that she was feeling weak; blood glucose obtained (result 101); patient was placed in bed, insulin drip rate changed to 0; rn noted that the bag of insulin was empty, and an extensive amount of air was in the line.The pump never beeped that air was in the line.The pump investigation revealed that the pump was programmed correctly, and the administered amount was.44ml despite the entire 100ml having flowed into the patient.The pump had been sequestered and all tubing left intact when evaluated, the tubing was loaded in the chamber correctly and no issues identified with the tubing.Clinical engineering found no issues with the pump either.Fda safety report id # (b)(4).

• Brand Name: BD ALARIS IV INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BD ALARIS/CAREFUSION 303, INC.; san diego CA 92130
• MDR Report Key: 11163178
• MDR Text Key: 227024594
• Report Number: MW5098783
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 86