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

Model Number DD+ELISIO-25H

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Local Reaction (2035); Increased Sensitivity (2065)

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.

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 6/19/19: 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.

Manufacturer Narrative

Investigation report is on retained samples only.(b)(4).

• Brand Name: NIPRO DIALYZER ELISIO-H (PP)
• Type of Device: DIALYZER
• Manufacturer (Section D): NIPRO CORPORATION (ODATE); 8-7 hanuki-yachi, nilda-aza; ohdate-shi, akita, 01857 94; JA 0185794
• MDR Report Key: 8750934
• MDR Text Key: 149767129
• Report Number: 9610987-2019-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00383790007139
• UDI-Public: 00383790007139
• Combination Product (y/n): N
• PMA/PMN Number: K140191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2019,07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: DD+ELISIO-25H
• Device Lot Number: 18L27E
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/01/2019
• Distributor Facility Aware Date: 06/06/2019
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other