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U.S. Department of Health and Human Services

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

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NIPRO CORPORATION (ODT) NIPRO ELISIO-H DIALYZERS Back to Search Results
Model Number DD+ELISIO-21H
Device Problems Improper or Incorrect Procedure or Method (2017); Output Problem (3005); Priming Problem (4040)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Clinic stated that they have experienced an increase in clotted dialyzers since switching from optiflux dialyzers to elisio dialyzers. Treatments are interrupted, and most are unable to return the patient's blood. The clotting is not patient, dialyzer size, or user specific. 7 total incidents reported in (b)(6): (b)(6) 2021 - 1 incident, (b)(6) 2021 - 2 incidents, (b)(6) 2021 - 1 incident, (b)(6) 2021 - 1 incident, (b)(6) 2021 - 1 incident. Clinical specialist contacted the facility and offered in-person product training for may 3, 4, and 5th 2021. Clinic was advised to follow ifu for proper priming instructions, because the staff was following clinic protocols and not the product ifu. After our clinical specialist visited the clinic and observed the staff during priming and recirculating process, it was identified that the clinic was recirculating with 100ml instead of 200ml as instructed in the ifu. Arterial chambers were also observed not be be 75% full in some cases. During her visit to the clinic, the nurse manager advised that a patient required a blood transfusion 2 days after treatment was interrupted and the patient's blood could not be returned due to the clotted dialyzer. All data was documented and an email with her findings was sent to the nurse manager, providing instructions for proper priming, recirc, and levels of bloodline chambers. Initial date of occurence is unknown. Clinic stated the first incident occurred sometime in (b)(6). Dialyzer size for product in question received 04/28/2021.
 
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Brand NameNIPRO ELISIO-H DIALYZERS
Type of DeviceDIALYZER
Manufacturer (Section D)
NIPRO CORPORATION (ODT)
8-7, hanuki-yachi, niida-aza
ohdate-shi, akita 018-5 794
JA 018-5794
MDR Report Key11898833
MDR Text Key281416612
Report Number1056186-2021-00012
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDD+ELISIO-21H
Device Catalogue NumberDD+ELISIO-25H
Device Lot Number20L14E
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2021
Distributor Facility Aware Date04/01/2021
Device Age4 MO
Event Location Outpatient Treatment Facility
Date Report to Manufacturer05/27/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 05/27/2021 Patient Sequence Number: 1
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