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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 ELISIO-17H
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problems Abdominal Pain (1685); Cyanosis (1798); Low Blood Pressure/ Hypotension (1914); Diaphoresis (2452); Pallor (2468)
Event Date 09/12/2022
Event Type  Injury  
Event Description
The hospital reported that allergic-like reactions appeared in 5 patients at about 5-55 min after hdf began between the dates of september 12 and september 15, 2022.Same product code and same lot number.Patient 1: hdf, patient was in cold sweat, pallor, cracked voice, with laryngeal edema at about 30 min.Patient 2: hdf, patient was in sweat, bp decreased more than 30mmhg at about 20 min.Patient 3: hdf, patient vomited, sweat profusely, limbs endings cyanosis at about 5 min.Patient 4: hdf, patient vomited, pruritus was seen at 10 min.Patient 5: hdf, patient was abdominal pain, vomited, sweat profusely at about 55 min.All the 5 patient haven't used 17h and hdf for over 1 month.The dialyzer of patient no.5 patient was kept.The hospital applied a self-inspection on the priming operation, dialysate quality, ro water quality, evaluate of the qb and qf, no abnormalities was reported, our local clinical specialist 're still concentrate on the actual operation.The priming volume is about 1000ml, the priming uses a flow at 80-100ml/min (500ml), then self circulation is applied, a faster flow (200ml/min) priming was after the self circulation (500ml).The hospital used ns for priming, the brand of ns is shimen, and the brand of the tube is cgst-003-e.Dialysate a is from huayue medical, dialysate b is from taishikang.Avf needle is jms.Dexamethasone was applied after the incidents happened, the nurse changed new tube and dialyzers(fb-17u) fot the patient, following treatment is hf-hd, the effects was meliorated after a instant treatment.In the incidents, hdf qb and qd was not available.We suggested the hospital use a lower qf flow and a lower hco3- concentration at the beginning of treatment while rising the qf flow up to target volume gradually.No side effects was found in the patient who restarted hdf.
 
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Brand Name
NIPRO ELISIO-H DIALYZER
Type of Device
DIALYZER
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 Key15666661
MDR Text Key302351126
Report Number9610987-2022-00009
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCH
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 10/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberELISIO-17H
Device Lot Number22F23C
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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