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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FMC- DIALYSIS MACHINE

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FMC- DIALYSIS MACHINE Back to Search Results
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem Tingling (2171)
Event Date 12/30/2016
Event Type  Injury  
Event Description
During the 3rd shift on b-side of the op dialysis unit, 3 patients were finished and 5 remained. The 5 were halfway done with their treatment when their machines began alarming sporadically and patients began to complain of tingling in hands and face. Some experienced moderate hypotension. Treatment stopped and blood was returned. Renal panels and blood cultures were obtained. Patients were given novasource. After labs were resulted, the patients were moved to a side for one hour hemodialysis with a 3k bath. Symptoms resolved and patients were discharged. This patient's signs and symptoms were tingling to hands and face. She was in chair 18. 2k bath. Units a and b are on different loops. Daily bicarb and acid added at 4:30am following routine process and usual staff. Ro water tested- normal. Storage tanks for bicarb checked after incident. No sludge seen. Conference call to fresenius (b)(6) 2017 to discuss incident and ask for assistance in determining possible cause.
 
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Brand NameFMC- DIALYSIS MACHINE
Type of DeviceFMC- DIALYSIS MACHINE
MDR Report Key6555479
MDR Text Key75361354
Report Number6555479
Device Sequence Number1
Product Code KDI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/09/2017,01/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/30/2016
Event Location Outpatient Treatment Facility
Date Report to Manufacturer01/17/2017
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 03/17/2017 Patient Sequence Number: 1
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