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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN UNKNOWN DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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UNKNOWN UNKNOWN DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problems Fall (1848); Injury (2348)
Event Date 03/31/2017
Event Type  malfunction  
Event Description
The wife of this patient was visiting her husband and while walking out of the unit to go home she slipped and fell and injured her right arm. Upon investigation, water was found on the floor in front of the room all the way through the unit to the door. It seems the dialysis machine that was used in the room was leaking when she took the machine out. Our dialysis that was used that day on that specific patient was inspected and no leaks were found. The water in the hallway was un-witnessed by anyone and could have come from other sources.
 
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Brand NameUNKNOWN
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
UNKNOWN
MDR Report Key6621580
MDR Text Key76973197
Report Number6621580
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/10/2017
Event Location Hospital
Date Report to Manufacturer05/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/08/2017 Patient Sequence Number: 1
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