MAUDE Adverse Event Report: NIPRO (THAILAND) CORP., LTD. NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR; BLOODLINE

Model Number A364R-V850R-GT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Sudden Cardiac Death (2510)

Event Date 04/28/2018

Event Type  Death  

Manufacturer Narrative

Investigation report attached is on retained samples only.Final investigation report is pending.

Event Description

On april 30, 2018, nipro was advised of a patient death while using a nipro product.On may 15, 2018 details of the event were received: the patient had an episode of hypotension during hemo-dialysis treatment.The nurse had to inject saline in order to stabilize the patient.Then first aid was applied due to cardiac arrest caused by arrhythmia.The patient passed away 36 minutes into the hemo-dialysis treatment.A nipro representative and clinical specialist met with the patient's physician, head nurse, and other physicians from the same region.They confirmed there was no embolism or clots found in the bloodline.They also confirmed the event to have been caused or most likely linked to the patient's health condition.Other medical devices used: elisio h dialyzer, surdial x dialysis machine.

Manufacturer Narrative

Investigation report attached is on retained samples only.Final investigation report is pending.

Event Description

On april 30, 2018, nipro was advised of a patient death while using a nipro product.On may 15, 2018 details of the event were received: the patient had an episode of hypotension during hemo-dialysis treatment.The nurse had to inject saline in order to stabilize the patient.Then first aid was applied due to cardiac arrest caused by arrhythmia.The patient passed away 36 minutes into the hemo-dialysis treatment.A nipro representative and clinical specialist met with the patient's physician, head nurse, and other physicians from the same region.They confirmed there was no embolism or clots found in the bloodline.They also confirmed the event to have been caused or most likely linked to the patient's health condition.Other medical devices used: elisio h dialyzer; surdial x dialysis machine.

Manufacturer Narrative

Investigation report is on retained samples only.Final investigation report is pending.6/8/2018: final investigation report is on actual used sample.Added codes to section h6.8/8/2018: manufacturer confirmed error in date of awareness, revised the following sections: section b5 - removed date "awareness date april 30, 2018" from complaint details.Section d10 - revised product returned to manufacturer date to "may 15, 2015".Section e3 - added occupation "other healthcare professional".Section g4 -revised manufacturer awareness date to "may 15, 2015".Section h6: added method code 3331.Removed method code 3340, 3317, 3330, 38, 3345, 3269.Removed conclusion code 71.

Event Description

Nipro was advised of a patient death while using a nipro product.On may 15, 2018, details of the event were received: the patient had an episode of hypotension during hemo-dialysis treatment.The nurse had to inject saline in order to stabilize the patient.Then first aid was applied due to cardiac arrest caused by arrhythmia.The patient passed away 36 minutes into the hemo-dialysis treatment.A nipro representative and clinical specialist met with the patient's physician, head nurse, and other physicians from the same region.They confirmed there was no embolism or clots found in the bloodline.They also confirmed the event to have been caused or most likely linked to the patient's health condition.Other medical devices used: elisio h dialyzer, surdial x dialysis machine.

Event Description

Nipro was advised of a patient death while using a nipro product.On may 15, 2018 details of the event were received: the patient had an episode of hypotension during hemo-dialysis treatment.The nurse had to inject saline in order to stabilize the patient.Then first aid was applied due to cardiac arrest caused by arrhythmia.The patient passed away 36 minutes into the hemo-dialysis treatment.A nipro representative and clinical specialist met with the patient's physician, head nurse, and other physicians from the same region.They confirmed there was no embolism or clots found in the bloodline.They also confirmed the event to have been caused or most likely linked to the patient's health condition.Other medical devices used: elisio h dialyzer.Surdial x dialysis machine.

Manufacturer Narrative

Investigation report attached is on retained samples only.Final investigation report is pending.On 6/8/18: final investigation report attached is on actual used sample.Added codes to section h6.On 8/8/18: manufacturer confirmed error in date of awareness, revised the following sections: section b5 - removed date "awareness date april 30, 2018" from complaint details.Section d10 - revised product returned to manufacturer date to "may 15, 2015".Section e3 - added occupation "other healthcare professional".Section g4 -revised manufacturer awareness date to "may 15, 2015".

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINE
• Manufacturer (Section D): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP., LTD.; 10/2 moo 8,; bangnomko, sena; ayuthaya, thailand, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 7569490
• MDR Text Key: 110084117
• Report Number: 8041145-2018-00017
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A364R-V850R-GT
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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): Death