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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDISYSTEMS CORPORATION STREAMLINE; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
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MEDISYSTEMS CORPORATION STREAMLINE; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS Back to Search Results
Catalog Number SL-200M2095
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2015
Event Type  malfunction  
Event Description
The arterial bulb of the lines on the dialysis machine was found to be clear and flattened.The blood pump was stopped and the saline line was opened to fill the bulb, which was hooked back up to the machine.The bulb immediately went clear and flat.The blood pump was again stopped and saline line re-opened; saline came out of the transducer line.When the line was clamped the saline flow would stop; when saline line was unclamped, the saline would start flowing again.The machine was stripped of all lines, did not return blood; machine restrung with new line setup and restarted patient's dialysis.No problems with new lines.
 
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Brand Name
STREAMLINE
Type of Device
ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
Manufacturer (Section D)
MEDISYSTEMS CORPORATION
350 merrimack st
lawrence, MA 01843
MDR Report Key5317956
MDR Text Key34108229
Report Number5317956
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 Other
Type of Report Initial
Report Date 12/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Nurse
Device Expiration Date06/30/2018
Device Catalogue NumberSL-200M2095
Device Lot Number50655042
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/10/2015
Device Age1 DY
Event Location Outpatient Treatment Facility
Date Report to Manufacturer12/10/2015
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
Treatment
NO OTHER THERAPIES
Patient Age63 YR
Patient Weight58
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