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Model Number DD+CT19H
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Event Date 06/06/2019
Event Type  Injury  
Manufacturer Narrative
Event Description
1 hour into dialysis treatment, the patient complained of itchiness and hives were noted on both lower and upper extremities and back. No benadryl was given and treatment was discontinued after 2 hrs of treatment, staff stated itchiness was better but redness still visible and patient was sent home. Patient will return on (b)(6) 2019 and will be put on rexeed dialyzer, which was the dialyzer she was previously using. The physician stated they will give the patient a week rest and will try again next thursday ((b)(6) 2019) on elisio dialyzer again but will prime the elisio with more saline (1. 5 l), as they already prime the elisio 25h with 1 l of saline. Patient was given aranesp 40 mcg, hectorol 1 mcg and iron 125 mg during treatment, which are not new medications for her. 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. Additional information received (b)(6) 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. This is the same patient that had a reaction to elisio (b)(6) 2019 ((b)(4)).
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Type of DeviceDIALYZER
Manufacturer (Section D)
8-7 hanuki-yachi, nilda-aza
ohdate-shi, akita, 01857 94
JA 0185794
MDR Report Key8750954
MDR Text Key149768603
Report Number1056186-2019-00008
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 Date03/31/2022
Device Model NumberDD+CT19H
Device Lot Number19D01C
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 Age2 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