MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

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

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 02/05/2020

Event Type  Death  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Clinical investigation: there is a temporal relationship between hd therapy using the fresenius 2008t machine and the patient event of cardiac arrest and death.However, there is no documentation in the complaint file to show a causal relationship between the two.Additionally, there was no allegation of a machine malfunction.The patient had no complaints at the start of treatment but became unresponsive minutes after being administered venofer and an increased dose of micera.The patient had been receiving 50mcg of micera every two weeks, however, this was the first treatment to receive 100mcg.The patient had not experienced any adverse event prior to this treatment.It is known in micera escalation doses that patients with chronic renal failure are at increased risk for mortality with serious cardiovascular events.In addition, end stage renal disease patients have mortality rates up to 30 times higher than the general population with sudden cardiac death as the leading cause in these patients.Based on the available information, no allegation of a machine malfunction or deficiency and no reported machine issues or alarms, the 2008t machine can be excluded as the cause of the patient¿s cardiac arrest and death.

Event Description

A user facility clinic manager (cm) reported that patient expired during hemodialysis (hd) treatment on a fresenius 2008t machine, after receiving venofer and micera.The patient reportedly exhibited signs of a seizure and then coded.Cardiopulmonary resuscitation (cpr) was performed but was unsuccessful.The patient was pronounced deceased.Upon follow up, additional information was obtained from the cm.The patient¿s pre-treatment vital signs were blood pressure (bp) 146/90 (sit), 131/87 (stand), pulse 97 regular, respiration 16, and temperature 98.8.The treatment goal was set to 100 due to patient negative (-2.0kg) weight gain.The patient¿s access site was cleaned and flushed with 10cc of normal saline without difficulty.The patient had no complaints, was negative for edema and lungs were clear bilaterally.Hd treatment was initiated at 1325 hours with a bp 156/87, and pulse 87.At 1329 hours venofer 100mg intravenous (iv) push (11th dose ever received) was administered.Venofer was given once weekly.At 1335 hours micera 100mcg ivp (4th dose ever received) was administered.This was given every two weeks.However, this was a new dosage.The physician had increased the micera dosage from the original dose of 50mcg every two weeks due to no improvement in hemoglobin from 8.2 over several weeks.The patient had never experienced any reactions to either medication.At 1338 hours the patient¿s father was overheard asking the patient if he was ok.The technician immediately attended to the patient who displayed seizure-like symptoms and a nurse was called.At 1339 hours (14 minutes into treatment) treatment ended and at 1340 hours the patient became unresponsive.The patient was placed in the trendelenburg position and rinsed back, and then the lines were disconnected.The patient had agonal breathing.Cardiopulmonary resuscitation (cpr) was initiated with chest compressions and 911 was called.Breaths were given via ambu (air-shields manual breathing unit) bag and the automated external defibrillator was applied with a reading done.The patient¿s glucose was checked and documented as 133.At 1343 hours emergency medical services (ems) arrived.At 1345 hours the patient was intubated, and ems took over the code.Cpr was terminated at 1418 hours per the paramedic and the coroner was called to pronounce the patient.The patient expired at the clinic.The cause of death was documented as cardiac arrest.There were no issues with the 2008t machine prior to or during treatment, and no alarms prior to the patient coding.There was no allegation of a machine malfunction or deficiency reported for this event.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9778358
• MDR Text Key: 181715332
• Report Number: 2937457-2020-00415
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: OPTIFLUX 180NRE DIALYZER
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 42 YR
• Patient Weight: 67