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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODATE) NIPRO DIALYZER ELISIO-H (PP) Back to Search Results
Model Number DD+ELISIO-25H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Itching Sensation (1943); Reaction (2414)
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
During dialysis treatment, the patient complained of itchiness, redness was noticed at the back of her neck (2x2 cm). The facility administrator mentioned that maybe the reaction was from the new shirt the patient was wearing. Patient was able to complete the treatment, but when the patient reached home, the patient stated the itchiness worsened and noticed more redness on multiple areas. Dialysis treatment order: patient dialyzed 3. 5 hrs, bfr
=
500, dfr
=
800. Heparin with 1000 units bolus and 1000 units/hr stop 1 hr before end of treatment. Meds administered: hectorol 1 mg and iron 125 mg (has been given these medications before without issues). Additional information received 6/19/2019: patient is doing good now with the elisio dialyzer, the staff is now priming with 1. 5 l of saline and patient has not had any reactions during treatment.
 
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Brand NameNIPRO DIALYZER ELISIO-H (PP)
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODATE)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
MDR Report Key8750890
MDR Text Key149766498
Report Number1056186-2019-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Model NumberDD+ELISIO-25H
Device Lot Number18L27E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/01/2019
Distributor Facility Aware Date06/06/2019
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer07/01/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/01/2019 Patient Sequence Number: 1
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