MAUDE Adverse Event Report: MEDISYSTEMS CORP. /NXSTAGE MEDICAL, INC. STREAMLINE AIRLESS SYSTEMS SET; SET,TUBING,BLOOD,WITH AND WITHOUT ANTI-REG

Catalog Number SL-2000M205

Device Problems Component Missing (2306); Defective Device (2588); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Reporter states dialysis clinic has been having multiple, ongoing issues with tubing as early as 2016.She reports tubing is often kinked, missing clamps, missing filters, or sometimes monitoring lines do not work.The product quality has affected patients treatment and at times unable to return blood back to patient.

• Brand Name: STREAMLINE AIRLESS SYSTEMS SET
• Type of Device: SET,TUBING,BLOOD,WITH AND WITHOUT ANTI-REG
• Manufacturer (Section D): MEDISYSTEMS CORP. /NXSTAGE MEDICAL, INC.
• MDR Report Key: 8608471
• MDR Text Key: 145279629
• Report Number: MW5086619
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SL-2000M205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1