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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO ELISIO-H DIALYZER

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NIPRO CORPORATION (ODATE) NIPRO ELISIO-H DIALYZER Back to Search Results
Model Number DD+ELISIO-15H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)
Event Date 03/24/2020
Event Type  malfunction  
Event Description
With 2 hours left of dialysis treatment, staff noticed that blood was visible on the arterial hanson dialysate line. Treatment was stopped and terminated immediately, blood was not returned. The dialysis machine was pulled out of the hospital unit floor and no new set up was started. Patient had shortness of breath, but staff was not sure if the patient had these symptoms prior to treatment. Treatment info: time
=
4 hrs. Bfr/dfr
=
300/600. Heparin
=
got 1900 units during treatment (didn't specify if it's bolus/maintenance). No other medications during treatment. Has cvc. Using gambro machine. 5th treatment on elisio. Additional information received 03/30/2020: cause of patient death was natural; per coroner. Blood cultures were obtained and negative on day of event. Patient had multiple comorbidities including chf (congestive heart failure) with reduced ejection fraction, af(arterial fibrillation) with rvr(rapid ventricular rate), ckd(chronic kidney disease), and obesity. He did not tolerate hd due primarily to hypotension on treatment with inability to remove fluid and was massively fluid overloaded. Patient did not wish to pursue dialysis, and chose a comfort based approach after a trial of hd. He was imminently dying and family was supportive of his decision to pursue comfort/hospice care.
 
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Brand NameNIPRO ELISIO-H DIALYZER
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
MDR Report Key9935741
MDR Text Key204581640
Report Number1056186-2020-00003
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 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Model NumberDD+ELISIO-15H
Device Catalogue NumberDD+ELISIO-17H
Device Lot Number17L18F
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/07/2020
Distributor Facility Aware Date03/25/2020
Device Age27 MO
Event Location Hospital
Date Report to Manufacturer04/07/2020
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: 04/08/2020 Patient Sequence Number: 1
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