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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODT) NIPRO ELISIO-H DIALYZER Back to Search Results
Model Number ELI-19H-PO-GJ
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Diaphoresis (2452)
Event Date 02/14/2022
Event Type  Injury  
Event Description
50 minutes after connection and treatment initiated, there was a drop in blood pressure. Machine alarmed. Patient was experiencing symptoms of abdominal pain, sweating, vomiting (allergic reactions). Dialysis session was stopped and the patient's blood was returned. Patient was administered polaramine injection. Patient had no further complications or symptoms. Other disposables used: fresenius dialysis machine 5008, fresenius bloodlines - f0000387. Dialysis conditions: hdf online; blood flow rate: between 350 and 260 ml/min; dialysate flow rate: 600 ml/min; heparine volume: 0. 4. Pressure at the beginning of the treatment: arterial pressure: -255; venous pressure: 300.
 
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Brand NameNIPRO ELISIO-H DIALYZER
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODT)
8-7, hanuki-yachi, niida-aza
ohdate-shi, akita 018-5 794
JA 018-5794
Manufacturer (Section G)
NIPRO CORPORATION (ODT)
8-7, hanuki-yachi, niida-aza
ohdate-shi, akita 018-5 794
JA 018-5794
Manufacturer Contact
michelle tejada
3150 nw 107th avenue
miami, FL 33172
3055997174
MDR Report Key13792543
MDR Text Key292196277
Report Number9610987-2022-00001
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 Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberELI-19H-PO-GJ
Device Lot Number21C29B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/17/2022 Patient Sequence Number: 1
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