MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS, SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2426-0007

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/07/2021

Event Type  malfunction  

Event Description

Patient receives magnesium chloride 3 gram weekly through her port.Port was accessed and infusion hooked up with bd alaris pump infusion set tubing ref (b)(4).Pump was scanned and programmed, when i noticed that blood was coming back through the port access tubing and dripping onto the patient's shirt.The tubing from the pump was no longer connected, but the end of the tubing that connects to the clave was still connected.The tubing had snapped/broken off right at the connector.It was a clean snap like it was defective tubing.Fortunately, it was noticed right away so the patient did not keep bleeding through the connector, but it did require getting another medication and tubing.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 12480523
• MDR Text Key: 271670379
• Report Number: 12480523
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/13/2021

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: No Information
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 21059024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2021
• Date Report to Manufacturer: 09/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA