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

Catalog Number 10794983

Device Problems Break (1069); Failure to Infuse (2340)

Patient Problem Insufficient Information (4580)

Event Date 01/19/2021

Event Type  malfunction  

Event Description

Patient in critical condition started to show rapid deterioration, multiple interventions were being done to stabilize patient and upon going to connect epi drip, it was noted that the bi-extension set which multiple infusions (norepi, tacro, milrinone) were infusing had broken off from the lumen.The luer lock piece was still attached, however, the plastic part was broken and therefore noted that these drugs were not infusing to the patient.It is unknown exactly how long these drugs were not infusing as the area did not seem wet.Tubing connections changes promptly, lumen flushed well with no issues, drugs re-started and epi drip started as well.Manufacturer response for y-site connection tubing, bd extention set smallbore tubing (per site reporter): they are following up on this event, and have entered a report of this event to fda as well.They are in the process of investigating.

• Brand Name: ALARIS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 11445290
• MDR Text Key: 238666278
• Report Number: 11445290
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/01/2021

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 Catalogue Number: 10794983
• Device Lot Number: (10) 20095142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6205 DA