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Model Number DD+ELISIO-15H
Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)
Patient Problems Infiltration into Tissue (1931); Blood Loss (2597)
Event Date 12/17/2018
Event Type  Injury  
Manufacturer Narrative
Investigation report still in progress.
Event Description
27 min into the dialysis treatment, the machine alarmed for minor blood leak, the staff tested it with a blood leak test strip and results were positive. They were unable to return the patient's blood, the machine was switched, and while setting up new dialyzer and bloodlines, the patient infiltrated and could not restart treatment. Patient left the dialysis unit stable, temperature was 96. 5 right after machine alarmed for blood leak, temperature was 96. 4 when discharged from unit. Since the staff was unable to return the patient's blood, 300 ml of blood was lost. Patient's physician and clinical coordinator were aware of the issue. Physician increased dose of venofer and order to recheck hemoglobin level on next scheduled treatment. Patient's regular dialysis treatment was rescheduled for (b)(6) 2018 due to infiltration, staff was unable to draw labs. Patient is being scheduled for vascular access intervention (angioplasty) on (b)(6) 2018. Treatment was started at 6:07 am and medication was given at 6:28 am. Patient's access is a left upper av fistula. Treatment orders: 210 mins treatment, 3k, 2. 5 ca, bicarb 32, sodium 138, bfr 400, dfr 600, heparin bolus 2000 units and 600 units/hour, medication - epogen 10,000 units ivp , venofer order was 50 mg weekly on that day ivp , hectorol 3. 5 mcg ivp and zone bar po. Other devices used: fresenius 2008 k2 dialysis machine.
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Type of DeviceDIALYZER
Manufacturer (Section D)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
MDR Report Key8201183
MDR Text Key131583152
Report Number1056186-2018-00015
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 Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Model NumberDD+ELISIO-15H
Device Lot Number18B22F
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2018
Distributor Facility Aware Date12/17/2018
Device Age10 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer12/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/27/2018 Patient Sequence Number: 1