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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 ELISIO-21H
Device Problem Contamination (1120)
Patient Problems Abdominal Pain (1685); Weakness (2145)
Event Date 10/16/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
Staff reported that immediately after connecting the patient to the dialysis machine, patient complained of abdominal pain, weakness and strange feeling. Patient's blood pressure was 208/89 with a pulse of 58. Staff also noticed the upper part of the dialyzer had a pinkish fluid. Machine did not alarm for blood leakage. Priming conditions: priming rinse with 800ml. Dialysis conditions: bfr-200ml/min, dfr-500ml/min. No additional information was provided.
 
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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 33172
3055997174
MDR Report Key9370490
MDR Text Key167968575
Report Number9610987-2019-00013
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
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberELISIO-21H
Device Lot Number18L06E
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 Received10/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2018
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: 11/25/2019 Patient Sequence Number: 1
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