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

Model Number ELISIO-19H

Device Problem Leak/Splash (1354)

Patient Problems Weakness (2145); Dizziness (2194); Sweating (2444)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

Investigation report attached is on retained samples only.Actual used device was discarded by end user.

Event Description

Staff reported that during the night shift, a patient complained of sudden weakness, dizziness, and sweating during the connection of dialysis treatment.At the point of examination by the nurse, a blood leak was visibly noticed through the red dialyzer doupler.No patient demographics or further information has been provided.Machine was primed with 800ml of saline.Dialysis conditions: bfr 200ml/min, dfr 500ml/min.Other devices used: nipro blood tubing set: a372r/v858r.Dialysis machine: surdial x.

Manufacturer Narrative

Investigation report attached is on retained samples only.Actual used device was discarded by end user.12/10/19: additional information was added to complaint description, lot number and expiration date was added.Final investigation report attached.Attachment: [manufacturer investigation report.Pdf, odt+report (b)(4).Pdf].

Event Description

Staff reported that during the night shift, a patient complained of sudden weakness, dizziness, and sweating during the connection of dialysis treatment.At the point of examination by the nurse, a blood leak was visibly noticed through the red dialyzer doupler.No patient demographics or further information has been provided.Machine was primed with 800ml of saline.Dialysis conditions: bfr 200ml/min, dfr 500ml/min.Other devices used: nipro blood tubing set: a372r/v858r.Dialysis machine: surdial x.Additional questions sent to customer, answers received 12/05/2019: did the patient complete the treatment that day? yes.The patient was connected to a different elisio 19h and a new bloodline set.The patient was connected to oxygen and blood tests were taken.The patient recovered.Did the patient loose blood? if so, how much blood was lost? the blood was returned to the patient when the dialyzer and blood tubing set was changed.However, information on the blood loss from the dialyzer leak point could not be obtained.At what point during treatment was the leak found? the blood was flowing inside of tube through the red dialyzer coupler into the machine.Leakage was observed in the dialyzer itself.

• Brand Name: NIPRO ELISIO-H HEMODIALYZER (ODT)
• 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: 9344697
• MDR Text Key: 167188715
• Report Number: 9610987-2019-00012
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K131935
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

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: 03/31/2022
• Device Model Number: ELISIO-19H
• Device Lot Number: 19D04B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 10/16/2019
• Supplement Dates FDA Received: 12/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention