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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDISYSTEMS CORP. STREAMLINE AIRLESS SYSTEM SET; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
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MEDISYSTEMS CORP. STREAMLINE AIRLESS SYSTEM SET; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS Back to Search Results
Lot Number 50355074
Device Problem Loose or Intermittent Connection (1371)
Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 07/17/2015
Event Type  malfunction  
Event Description
A blood leak was noticed and seemed to originate from the heparin line which was clamped and capped.Dialysis was stopped and fluids were given for hypotension.Patient was stabilized, blood pressure returned to baseline.Upon further inspection, it was noted the on/off clamp on the tubing was not completely clamping off the tubing even though in the closed position.Manufacturer response for dialysis tubing, streamline airless system set (per site reporter): they are sending a return box for the tubing.
 
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Brand Name
STREAMLINE AIRLESS SYSTEM SET
Type of Device
ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
Manufacturer (Section D)
MEDISYSTEMS CORP.
350 merrimack street
lawrence MA 01843
Manufacturer Contact
350 merrimack st
lawrence, MA 01843
MDR Report Key5077131
MDR Text Key25776450
Report Number5077131
Device Sequence Number1
Product Code KOC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 08/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2015
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Lot Number50355074
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/26/2015
Device Age1 DY
Event Location Outpatient Treatment Facility
Date Report to Manufacturer08/26/2015
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 Number1
Patient Outcome(s) Other;
Patient Age73 YR
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