MAUDE Adverse Event Report: MEDISYSTEMS CORP. STREAMLINE; SYSTEM, HEMODIALYSIS

Model Number SL-2000M2095

Device Problems Leak/Splash (1354); Material Rupture (1546); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

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

Event Date 10/01/2014

Event Type  malfunction  

Event Description

Venous alarm was alarming, upon inspection of machine, venous pod was ruptured and blood went to machine's venous pressure detector.There was no patient harm and no hemodialysis equipment failure.The dialysis tubing leaked blood from the pathway into a monitor line.This will be sent to the manufacturer if they request for evaluation of possible defect in the tubing.No bloodleak into the dialysis pathway and no blood loss for the patient.

• Brand Name: STREAMLINE
• Type of Device: SYSTEM, HEMODIALYSIS
• Manufacturer (Section D): MEDISYSTEMS CORP.; 350 merrimack st; lawrence MA 01843
• MDR Report Key: 4264199
• MDR Text Key: 5108012
• Report Number: 4264199
• Device Sequence Number: 1
• Product Code: FJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: SL-2000M2095
• Device Lot Number: 40655010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2014
• Patient Sequence Number: 1
• Patient Age: 69 YR