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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDISYSTEMS CORP. STREAMLINE; TUBING, DIALYSIS
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MEDISYSTEMS CORP. STREAMLINE; TUBING, DIALYSIS Back to Search Results
Model Number SL-200M2095
Device Problems Deflation Problem (1149); Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 08/09/2014
Event Type  malfunction  
Event Description
Patient wanted to use the restroom, so hemodialysis technician reinfused the patient's blood according to protocol.Patient was disconnected from dialysis machine and went to the bathroom, hemodialysis technician hooked up the patient's circuit to saline to recirculate the machine, and noticed the arterial streamline pod was deflated, by procedure to fix this hemodialysis technician unhooked the line attached to the transducer while the pump was off to fill the arterial pod.Instead of the pod filling it leaked out into the line, which is not supposed to occur.Hemodialysis technician took down this setup and primed a new system.Patient was safely put back on the machine and resumed treatment.Reported to medisystems and they are sending a box to send the tubing to them for investigation.
 
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Brand Name
STREAMLINE
Type of Device
TUBING, DIALYSIS
Manufacturer (Section D)
MEDISYSTEMS CORP.
350 merrimack st
lawrence MA 01843
MDR Report Key4131324
MDR Text Key4935588
Report Number4131324
Device Sequence Number1
Product Code FJK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 09/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Model NumberSL-200M2095
Device Lot Number40655095
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/18/2014
Event Location Hospital
Date Report to Manufacturer10/01/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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