MAUDE Adverse Event Report: BD / CAREFUSION 303, INC. INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 06/07/2019

Event Type  Injury  

Event Description

Potassium 20 meq / 100 ml - infuse at 10 meq/hr ordered.Pump was programmed correctly and tubing was properly inserted in pump by rn.Pump gave medication too fast.It was 20 meq in 100 ml.Pump gave approx 5 meq in 10 mins, despite being programmed to run in over 2 hours.

• Brand Name: INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION 303, INC. ; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 8826388
• MDR Text Key: 152321850
• Report Number: MW5088360
• 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: 06/27/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8100
• Device Lot Number: 19045580INFUSIONSET
• 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: 73 YR
• Patient Weight: 65