MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190371

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

Patient Problems Cardiac Arrest (1762); Death (1802); Respiratory Failure (2484)

Event Date 12/29/2017

Event Type  Death  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.The 2008k hemodialysis (hd) machine was evaluated at the user facility by the fresenius regional equipment specialist (res).The res verified that the machine functioned per specification and completed all functional checks.The unit was returned to service at the user facility without any issues.A records review was performed on the reported serial number.An investigation of the device history records (dhr) 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 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.The res verified that the machine was operating properly, and the user facility suspected that there was a mixing error.Therefore, the complaint is not confirmed.

Event Description

A biomedical engineer (biomed) at a user facility reported that a patient expired during hemodialysis (hd) treatment while on a fresenius 2008k hd machine.The biomed stated that the electrolytes drawn from the hd machine after patient expired during dialysis treatment with the following results: (sodium) na+ set at 140, lab results were 145; (potassium) k+ set at 4k, lab results were 3.2k.This was an acute patient and it was the patient¿s first hd treatment.The patient had just been transferred to this facility from another hospital that was located in a rural area and could not provide adequate care.The patient was in the other hospital for at least four days and had been transferred after myocardial infarction (mi).During the hd treatment, the patient was on a ventilator.It was reported that the patient was in poor health and hd was one of the last efforts attempted to prevent the patient from expiring.The patient¿s final diagnoses were vfib, cardiac arrest, des, cardiogenic shock, acute hypoxic respiratory failure, hypothermia, hagma, hyperglycemia, lactic acidosis, leukocytosis following cardiac arrest, aki, shock liver, hypomagnesia, hypocalcemia, hypokalemia, hypertension, and hlb.It was unknown if there were any machine alarms prior to or during the hd treatment.There was no suspected device defect or malfunction, however, the machine was removed from service following the event for testing.It was further reported that the dialysate shown the potassium result to be 3.2, when the prescription was set to 4, and the sodium result was 145, but the prescription was set to 140.The machine¿s service record was reviewed by the facility and there were no issues found, therefore, it was suspected that there was a mixing error.The acid concentrate bath was in fact 2k and the staff had not added potassium chloride as they were supposed to have done.Following these results, a fresenius regional equipment specialist (res) performed on-site service.The res verified machine operations.The res reported base lab values as the following: acid (a)min 13.45 - amax 14.0, with the results of 13.9 ml; bicarb (b)min 24.2 - bmax 25.19, with the result of 24.9.The res confirmed that the machine functioned per specification and completed all functional checks.The machine was returned to service at the user facility without issue.No devices are available to be returned to the manufacturing plant for physical evaluation.

Manufacturer Narrative

Additional information - clinical investigation: a temporal relationship exists between the 2008k hemodialysis (hd) machine, and the collective concentrates - acid, bicarbonate, and the adverse events of cardiac arrest and subsequent death.The patient death is most likely due to multiple comorbidities and presenting medical state which included: ventricular fibrillation, cardiac arrest cardiogenic shock, acute kidney failure, acute hypoxic respiratory failure with ventilator, lactic acidosis leukocytosis, liver shock, myocardial infarction, hyperglycemia, hypothermia, hypomagnesia, hypocalcemia, hypokalemia and hypertension.There is no documentation or evidence indicating a causal relationship between the 2008k hd machine, and the collective concentrates - acid, bicarbonate, and the adverse events, as the machine performed within specification during follow-up functional compliance testing.There is no allegation that any fresenius device malfunctioned or failed to perform as expected.There is a possibility that there may have been a mixing error during set-up, which may have attributed to the variation in electrolyte readings; the consequences of this is unknown.

Event Description

Follow-up information was received from the fresenius regional equipment specialist (res) who had performed on-site service.The res stated that the hemodialysis machine was tested with a naturalyte 2251 2k 2.5ca 1mg gal, which was the same product that the patient had used for dialysis treatment.There was hand-written permanent black marker writing on the naturalyte jug that read "4k 2.5ca" and also had a date in marker that said "(b)(6)".There were also two symbols, that appeared to look like circles, hand written in marker on the jug but there is no explanation as to what the symbols mean.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7205363
• MDR Text Key: 97729242
• Report Number: 2937457-2018-00196
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2005
• 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: FRESENIUS ACID CONCENTRATE; FRESENIUS BICARBONATE; FRESENIUS F160 DIALYZER; MEDISYSTEMS STREAMLINE BLOODLINES 8MM
• Patient Outcome(s): Death
• Patient Age: 39 YR