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

Model Number SL-2000M2095

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 03/01/2019

Event Type  malfunction  

Event Description

Arterial line connecting to dialyzer became disconnected; leading to a blood loss via the dialyzer being open on the bottom.Patient will require for hgb to be monitored.

• Brand Name: STREAMLINE AIRLESS SYSTEM SET
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): MEDISYSTEMS CORP
• MDR Report Key: 8401713
• MDR Text Key: 138228257
• Report Number: MW5084732
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2021
• Device Model Number: SL-2000M2095
• Device Lot Number: 81255006
• Was Device Available for Evaluation?: Yes
• 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: 68 YR
• Patient Weight: 106