MAUDE Adverse Event Report: BECTON DICKINSON & CO. ALARIS PUMP INFUSION SET; PUMP TUBING

Lot Number (10) 20105260

Device Problem Increased Pump Speed (1501)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 01/04/2021

Event Type  Injury  

Event Description

Tubing primed, in channel and hooked to patient.Pump programmed to correct rate.Two nurses in room with patient.Two other channels programmed and working.Pump free-flowed entire bottle of versed.Patient already intubated and safe.Alaris brain and all channels removed and sent to risk.New brain and channels used with patient.Tubing was primed and connected to patient.Iv started to drip on its own.Unknown if this is a pump or tubing issue.

• Brand Name: ALARIS PUMP INFUSION SET
• Type of Device: PUMP TUBING
• Manufacturer (Section D): BECTON DICKINSON & CO. ; franklin lakes NJ
• MDR Report Key: 11308958
• MDR Text Key: 231335939
• Report Number: 11308958
• Device Sequence Number: 1
• Product Code: FRN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: (10) 20105260
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 62 YR