MAUDE Adverse Event Report: CAREFUSION 303, INC. AS LVP 20D 3SS CV BV; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 11522558

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Event Description

Oncology patient getting chemo infusion through circle primed tubing with blue ball that normally drops and prevents air from entering tubing.Ball dropped but pump did not beep off occluded as it does normally and instead drew air into the tubing that did not reach the pump before this nurse noticed.Most likely the pump would have alarmed air in line if very large air bubble had gotten to that part, but it might not have and could have caused air embolism and resulted in patient harm make it policy again to under dial volume to safeguard from incidents if this equipment malfunctions again.Also evaluate why this is happening with the tubing, as it is supposed to be prevented by the blue ball.Summary of biomed check of device work completed: "found unit in the clean utility room ready for use.Checked unit's condition, failed rate accuracy, preformed rate accuracy calibration and repeated unit verification.All tests passed." there was no harm involved, this was an "unplanned barrier catch".

• Brand Name: AS LVP 20D 3SS CV BV
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 11634432
• MDR Text Key: 244440943
• Report Number: 11634432
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: CURRENT LOT # 20116053
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 210 DA