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

Model Number DD+ELISIO-25H

Device Problem Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/11/2022

Event Type  malfunction  

Event Description

1 hour into dialysis treatment, machine alarmed for blood in the dialysate.Staff was unable to confirm blood leak with a blood leak strip.Bfr of 440ml/hr and dfr of 800ml/hr.Treatment was stopped, blood was not returned.New machine set up was started and completed the treatment without issues.Patient's hgb at start of the month was 10g/dl.Labs will be drawn (b)(6) 2022 to see hgb levels.On (b)(6) 2022: clinic confirmed that they increased aranesp from 10mcg to 25mcg weekly.

Event Description

1 hour into dialysis treatment, machine alarmed for blood in the dialysate.Staff was unable to confirm blood leak with a blood leak strip.Bfr of 440ml/hr and dfr of 800ml/hr.Treatment was stopped, blood was not returned.New machine set up was started and completed the treatment without issues.Patient's hgb at start of the month was 10g/dl.Labs will be drawn (b)(6) 2022 to see hgb levels.On (b)(6) 2022: clinic confirmed that they increased aranesp from 10mcg to 25mcg weekly.

• 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 Key: 14380312
• MDR Text Key: 299969594
• Report Number: 9610987-2022-00002
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: DD+ELISIO-25H
• Device Lot Number: 21I27E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other