MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY ALARIS / LVP, PC UNIT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 8100 (LVP), 8015 (PCUNIT)

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 08/02/2020

Event Type  Injury  

Event Description

Utilizing alaris pump and module, potassium chloride 10 meq/100 ml was programmed utilizing the medication library "guardrails".Infusion was set to run at 100 ml/hr.Infusion was started (b)(6) 2020 at 22:28 and completed at 22:44, an elapsed time of 16 minutes.Nursing reported that the full 100 ml was infused, no leaks were noted above or below the module or at the iv site.Pump was verified to be programmed correctly per nursing administration and biomed.Total infusion per pump log was 26.3 ml (consistent with the time infused but is contra to there being no remaining fluid in bag).Fda safety report id# (b)(4).

• Brand Name: ALARIS / LVP, PC UNIT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 10419630
• MDR Text Key: 203490102
• Report Number: MW5096095
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8100 (LVP), 8015 (PCUNIT)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 88