MAUDE Adverse Event Report: MEDISYSTEMS MEDISYSTEMS; STREAMLINE

Catalog Number SL-2000M2095

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

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

Event Date 04/21/2017

Event Type  malfunction  

Event Description

Upon initiation of dialysis, noted blood coming from blood pump segment.Dialysis stopped, unable to return blood to pt.Ebl 200 ml.Upon inspection of old blood pump segment, it had a separation of 2.54 cm in length, on the superior side of the pump segment.A new line from the same lot, was pulled to reestablish the circuit, so dialysis could be restarted.The new line was visually inspected and noted to have the same defect as the line that was just removed for failure, of the blood pump segment.This lot was removed from service at this time, until issue resolved.Diagnosis or reason for use: end stage renal disease.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: MEDISYSTEMS
• Type of Device: STREAMLINE
• Manufacturer (Section D): MEDISYSTEMS; 520 merrimack street; lawrence MA 01843
• MDR Report Key: 6559848
• MDR Text Key: 75020771
• Report Number: MW5069683
• Device Sequence Number: 1
• Product Code: FJK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2019
• Device Catalogue Number: SL-2000M2095
• Device Lot Number: 61055043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 94