MAUDE Adverse Event Report: MEDISYSTEMS DIALYSIS STREAMLINE AIRLESS SYSTEM SET

Model Number SL-2000M2095

Device Problems Kinked (1339); Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

Our company has repeatedly reported quality concerns about medisystem streamline airless system sets.Problems include severe kinking which could result in pt injury due to hemolysis, monitoring lines that don't monitor correctly, leaking from lines.

• Brand Name: DIALYSIS STREAMLINE AIRLESS SYSTEM SET
• Type of Device: DIALYSIS STREAMLINE AIRLESS SYSTEM SET
• Manufacturer (Section D): MEDISYSTEMS
• MDR Report Key: 6885770
• MDR Text Key: 87300983
• Report Number: MW5072280
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2000M2095
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1