MAUDE Adverse Event Report: BECTON DICKINSON CO. ALARIS TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Gas/Air Leak (2946); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

Angiomax 50 ml bag scanned, hung and verified by second rn at 0240 on alaris pump.Angiomax running at 0.48 mg/kg/hr at 12.54 ml/hr.Bag empty in a little over 1 hour.Pump validation showed correct dose and rate.Md notified.Channel sequestered.All other channels on pump infusing correctly.I did not identify any programming errors that could have contributed to this event.The program was started at 0240 and the pump alarmed with air in the line (presuming it was empty) at 0333, 53 minutes later.The infusion report shows that only 11.1 mls should have infused when the bag was noted to be empty.I will get to mcr to photograph the pump and review the set up, then we can get the pump to ce for testing before returning to bd.Again, it is noteworthy that the majority of our over-infusions have involved low rate infusions.I will again bring this to the attention of bd.

• Brand Name: ALARIS TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON CO.; franklin lakes NJ 07417
• MDR Report Key: 16324047
• MDR Text Key: 309257423
• Report Number: MW5114775
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/03/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female