MAUDE Adverse Event Report: BD / CAREFUSION ALARIS INFUSION PUMP LVP (MODULE) + TUBING; SET, ADMINISTRATION INTRAVASCULAR

Lot Number 19046561

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 07/30/2019

Event Type  Injury  

Event Description

Infusion finished sooner than expected.Total volume infused 266.41 ml.Total volume infused should have been 400 ml.Privigen 40 mg order; mixed in 400ml.

• Brand Name: ALARIS INFUSION PUMP LVP (MODULE) + TUBING
• Type of Device: SET, ADMINISTRATION INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION
• MDR Report Key: 8982593
• MDR Text Key: 157755812
• Report Number: MW5089677
• Device Sequence Number: 2
• 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: 08/02/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 19046561
• 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 Age: 83 YR
• Patient Weight: 82