MAUDE Adverse Event Report: MEDISYSTEMS CORPORATION STREAMLINE AIRLESS SYSTEM; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number M535SL2010M20960

Device Problem Infusion or Flow Problem (2964)

Patient Problem Blood Loss (2597)

Event Date 09/04/2015

Event Type  malfunction  

Event Description

Rn completed dialysis treatment and hooked the normal saline blood return bag to the locksite connector.The connection would not allow the blood to be returned.Patient lost 120 ml of blood.After this failure rn tried to check the port with a syringe and was unable to push or pull any through the locksite.

• Brand Name: STREAMLINE AIRLESS SYSTEM
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): MEDISYSTEMS CORPORATION; 350 merrimack street; lawrence MA 01843
• MDR Report Key: 5129716
• MDR Text Key: 27552420
• Report Number: 5129716
• Device Sequence Number: 1
• Product Code: KOC
• 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
• Report Date: 09/08/2015,09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: M535SL2010M20960
• Device Lot Number: 50654009M
• Other Device ID Number: NC45-0341 REV G
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 56