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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODATE) NIPRO ELISIO-H HEMODIALYZER (ODT) Back to Search Results
Model Number ELISIO-19H
Device Problem Leak/Splash (1354)
Patient Problems Weakness (2145); Dizziness (2194); Sweating (2444)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
Investigation report attached is on retained samples only. Actual used device was discarded by end user.
 
Event Description
Staff reported that during the night shift, a patient complained of sudden weakness, dizziness, and sweating during the connection of dialysis treatment. At the point of examination by the nurse, a blood leak was visibly noticed through the red dialyzer doupler. No patient demographics or further information has been provided. Machine was primed with 800ml of saline. Dialysis conditions: bfr 200ml/min, dfr 500ml/min. Other devices used: nipro blood tubing set: a372r/v858r. Dialysis machine: surdial x.
 
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Brand NameNIPRO ELISIO-H HEMODIALYZER (ODT)
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 33172
3055997174
MDR Report Key9344697
MDR Text Key167188715
Report Number9610987-2019-00012
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeIS
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,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2022
Device Model NumberELISIO-19H
Device Lot Number19D04B
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 Received10/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2019
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: 11/19/2019 Patient Sequence Number: 1
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