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

Model Number A364R/V850R

Device Problems Partial Blockage (1065); Increase in Pressure (1491); Obstruction of Flow (2423)

Patient Problems Cardiac Arrest (1762); Fainting (1847); Convulsion, Clonic (2222)

Event Date 08/06/2018

Event Type  Injury  

Manufacturer Narrative

Final investigation will be submitted with the supplement report.(b)(4).

Event Description

Patient started his first hdf treatment using a central venous catheter (cvc) with a history of acute coronary syndrome.Max-sub system was used for optimizing the convective volume.Nurse has to place the lines inverted in the cvc because the venous lumen was more permeable than the arterial.Treatment ran well, tmp stabilized at 262 mmhg.Patient did not report any symptoms during the treatment, having normal vital signs throughout the treatment.Treatment was completed without alarms.Once the treatment was completed, the nurse began to return the patient's blood, the machine immediately alarmed 3 times for maximum venous pressure.Staff suspected the lines were obstructed by a clot, nurse was instructed toi decrease the qb to 100 ml/min, to return as much blood as possible.At the end of the return, the patient suddenly fainted, began to convulse, and immediately had a cardiorespiratory arrest.Staff performed resuscitation maneuvers, including defibrillation, for 40 minutes.Staff noticed the venous chamber was completely dirty with a huge clot, yet the dialyzer was clean.Patient was sent to the hospital with an endotracheal tube and sinus rhythm.(b)(6): the patient is currently in icu, sedated and stable.In an act image performed at the hospital, the icu physicians appreciated signs of pulmonary thromboembolism.It is very likely the patient will have irreversible brain injuries, prognosis is uncertain.(b)(6): patient's dialysis physician emailed nipro's staff and advised that "the patient remains with the same conditions in icu, patient apparently has lung cancer which may be the cause of the event.Patient has not had any major changes to his condition and continues with neurological deterioration".Patient's dialysis schedule: 3 days a week, 4 hour treatment, qb 450 ml/min, qd 500 ml/min, acid concentrate; dialtanc 324-a.Other equipment used: surdial x dialysis machine, max-sub system.

Manufacturer Narrative

Investigation report attached is the preliminary report on retained samples only.Final investigation will be submitted with the supplement report.5/1/19: final investigation report attached on retained samples only.- attachment: [initial investigation (qc180808-301).Pdf, final investigation report (qc180808-301).Pdf].

Event Description

Patient started his first hdf treatment using a central venous catheter (cvc) with a history of acute coronary syndrome.Max-sub sytem was used for optimizing the convective volume.Nurse has to place the lines inverted in the cvc because the venous lumen was more permeable than the arterial.Treatment ran well, tmp stabilized at 262 mmhg.Patient did not report any symptoms during the treatment, having normal vital signs throughout the treatment.Treatment was completed without alarms.Once the treatment was completed, the nurse began to return the patient's blood, the machine immediately alarmed 3 times for maximum venous pressure.Staff suspected the lines were obstructed by a clot, nurse was instructed toi decrease the qb to 100 ml/min, to return as much blood as possible.At the end of the return, the patient suddenly fainted, began to convulse, and immediately had a cardiorespiratory arrest.Staff performed resuscitation maneuvers, including defribillation, for 40 minutes.Staff noticed the venous chamber was completely dirty with a huge clot, yet the dialyzer was clean.Patient was sent to the hospital with an endotracheal tube and sinus rhythm.August 8: the patient is currently in icu, sedated and stable.In an act image performed at the hospital, the icu physicians appreciated signs of pulmonary thromboembolism.It is very likely the patient will have irreversible brain injuries, prognosis is uncertain.August 16: patient's dialysis physician emailed nipro's staff and advised that "the patient remains with the same conditions in icu, patient apparently has lung cancer which may be the cause of the event.Patient has not had any major changes to his condition and continues with neurological deterioration".Patient's dialysis schedule: 3 days a week, 4 hour treatment, qb 450 ml/min, qd 500 ml/min, acid concentrate; dialtanc 324-a other equipment used: surdial x dialysis machine max-sub system.

• 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; bangnomko, sena; ayuthaya,?, 13110 ; TH 13110
• MDR Report Key: 7813018
• MDR Text Key: 118132870
• Report Number: 8041145-2018-00018
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K072024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: A364R/V850R
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 18A21
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR