MAUDE Adverse Event Report: MPS MEDICAL INC / /MPS PHARMA & MEDICAL, INC. IV LIPID FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	EB-060-26
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Newborn, being treated in the nicu, had intravenous lipids infusing through a venous catheter.Iv pump had an error message of occlusion.Umbilical site was flushed and confirmed as patent.Unable to flush intravenous lipids through tubing filter, filter clogged.Tubing filter changed.No harm to the infant.Fda safety report id # (b)(4).

• Brand Name: IV LIPID FILTER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MPS MEDICAL INC / /MPS PHARMA & MEDICAL, INC.; brea CA 92821
• MDR Report Key: 13601960
• Report Number: MW5107715
• Device Sequence Number: 17443261
• Product Code: FPA
• UDI-Device Identifier: 00816513021308
• UDI-Public: (01)00816513021308(17)251204(10)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2025
• Device Model Number: EB-060-26
• Device Lot Number: M54439
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White