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

Model Number A372R-V858R

Device Problem Use of Device Problem (1670)

Patient Problems Convulsion, Tonic (2223); Sudden Cardiac Death (2510)

Event Date 05/10/2019

Event Type  Death  

Manufacturer Narrative

Investigation report attached is on retained samples for representative lot chosen by the manufacturer, since the customer did not retain product information.(b)(4).

Event Description

At 12:50 (b)(6) time, during the initiation of hemo-dialysis treatment, the machine alarmed with a message to "put venous line back in the venous port", the patient started to have a seizure, suffered sudden cardiac arrest and passed away.Patient has no medical history of seizures.According to the nurse in charge and attending physician, root cause of death is currently unknown.Additional information: per the clinic, the unit policy is to prime the machine with 500ml of normal saline, and to put the machine into re-circulation prior to connection to ensure all of the air bubbles are dispelled from the circuit.The nurse stated that the dialysis machine was in re-circulation and she stopped the pump, connected the patient and as the blood was priming the lines, the following message came up, "please re-insert the venous line into the drain port".The machine technician went to check the settings on the machine and check the history, to be able to pull all messages the machine generated during this event/treatment.Unfortunately, the machine was used 3 additional times since the event occurred, resulting in the treatment data and alarm conditions specific to the event, to be erased from its system.The unit did not have any records/data in regards to this treatment either.The nurse was sure that the machine was in recirculation, and tech checked to see if this specific message had ever come up as a software bug-message.Per the tech, in their experience, this message only pops up during priming if the priming has not been completed, making it possible for air to still be in the bloodlines when the patient was connected.Machine tech inspected the machine and it confirmed operation of the drain port in flowchart sensor switch ls16, operated as expected when the drain port is opened/closed.Tech also confirmed operation of air detector to be working as expected.Tech primed the machine with normal saline and confirmed the machine primed as expected without alarms.Customer was advised not to use the machine as a precaution until advised.Other devices used: sx dialysis machine, fresenius fx dialyzer.

• Brand Name: NIPRO BLOOD TUBING SET W/TRANSDUCER PROTECTOR
• Type of Device: BLOODLINES
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,?, 13110 ; TH 13110
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8, bangnomko, sena; ayuthaya,?, 13110 ; TH 13110
• Manufacturer Contact: michelle tejada ; 3150 nw 107 avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 8664742
• MDR Text Key: 146889145
• Report Number: 8041145-2019-00004
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A372R-V858R
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 43 YR
• Patient Weight: 74