MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK; FILTER, INFUSION LINE

Model Number 1C8740

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2017

Event Type  malfunction  

Event Description

Patient's bed found wet with tpn.Iv fluids leaking through small hole on filter in the line.Filter removed and iv fluids continued.

Event Description

Patient's bed found wet with tpn.Iv fluids leaking through small hole on filter in the line.Filter removed and iv fluids continued.

• Brand Name: INTERLINK
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 911 north davis; cleveland MS 38732
• MDR Report Key: 6521742
• MDR Text Key: 73684126
• Report Number: 6521742
• Device Sequence Number: 1
• Product Code: FPB
• 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,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1C8740
• Device Catalogue Number: 1C8740
• Device Lot Number: GR337006
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/24/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1