MAUDE Adverse Event Report: MPS MEDICAL INC. BIFURCATED IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Event Description

Bifurcated extension set would not infuse lipids through filter.Tpn infused without difficulty.Three different sets were tried.Staff reports that this is an ongoing problem with this product.The patient is not injured.However, the problem is time consuming and frustrating as replacement of the bifurcated extension set requires sterile procedure.

• Brand Name: BIFURCATED IV TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MPS MEDICAL INC.; 830 challenger st. suite 200; brea CA 92821
• MDR Report Key: 7302341
• MDR Text Key: 101140038
• Report Number: 7302341
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2018

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 Expiration Date: 10/17/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BAXTER IV PUMP; OTHER, TPN
• Patient Outcome(s): Other
• Patient Weight: 3