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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NIPRO CORPORATION (ODATE) NIPRO DIALYZER ELISIO-H
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NIPRO CORPORATION (ODATE) NIPRO DIALYZER ELISIO-H Back to Search Results
Model Number ELISIO-25H
Device Problem Insufficient Information (3190)
Patient Problems Fatigue (1849); Chest Tightness/Pressure (2463)
Event Date 11/08/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
After 10 minutes into dialysis treatment, patient feels faint and tightness of the chest, with a systolic = ap 70mmhg.Treatment was stopped.The patient's blood was not returned.Patient recovered well after oxygenation.He was dialyzed the same day with a different dialyzer brand (toray).No additional information was provided.
 
Event Description
After 10 minutes into dialysis treatment, patient feels faint and tightness of the chest, with a systolic = ap 70mmhg.Treatment was stopped.The patient's blood was not returned.Patient recovered well after oxygenation.He was dialyzed the same day with a different dialyzer brand (toray).No additional information was provided.
 
Manufacturer Narrative
On 02/26/2020: revised date of occurrence from 08/11/2019 to 11/08/2019.Investigation report attached is on retained samples only.Actual sample was discarded by the user.
 
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Brand Name
NIPRO DIALYZER ELISIO-H
Type of Device
DIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA  0185794
MDR Report Key9498482
MDR Text Key174850801
Report Number9610987-2019-00014
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K140191
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/31/2022
Device Model NumberELISIO-25H
Device Lot Number19F17E
Was Device Available for Evaluation? No
Date Manufacturer Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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