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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 ELI-21H-PO-GJ
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dyspnea (1816); Malaise (2359); Reaction (2414)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
During dialysis treatment, patient experienced allergic reactions, such as desaturation, dyspnea, malaise, anaphylaxis grade ii. Staff decided to stop treatment, blood was not returned, patient lost about 300ml of blood. Patient has been using elisio dialyzer since 2016 without complications. Staff continued dialyzing patient with a triacetate dialyzer without complications. Staff began to use solacea dialyzer for the following treatments. Other disposables used: bloodline sn-set onlineplus bvm 5008-r: lot z4ul091, bibag 5008 900g, bag bellco lympha 5, 5l ref 942. Dialysis machine: fresenius 5008 (no. 15024).
 
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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
Manufacturer (Section G)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
Manufacturer Contact
michelle tejada
3150 nw 107 avenue
miami, fl 
5997174234
MDR Report Key9782627
MDR Text Key188106006
Report Number9610987-2020-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131935
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberELI-21H-PO-GJ
Device Lot Number18I13C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/03/2020 Patient Sequence Number: 1
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