MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Dyspnea (1816); Pulmonary Edema (2020); Electrolyte Imbalance (2196); Respiratory Failure (2484)

Event Date 10/02/2017

Event Type  Death  

Manufacturer Narrative

Clinical investigation: although a temporal relationship exists between a 2008k hemodialysis (hd) machine and the patient¿s bradycardia during in-patient hd treatment with subsequent cardiac arrest resulting in patient death, there is no allegation against the machine or documentation that supports a causal relationship. The exact cause of the patient¿s cardiac arrest is unknown. However, it is likely the patient¿s complex acute comorbid conditions (peritoneal dialysis catheter failure, congestive heart failure, and pulmonary hypertension with acute respiratory failure (due to pulmonary edema vs. Pulmonary embolism) and hyperkalemia) as well as chronic diabetes and hypertension, may have been contributory factors in the patient¿s cardiac arrest and ultimate death. Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the serial number of the hemodialysis (hd) machine in question was not known. However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure" p/n 500658; a device is not released if it does not meet requirements or is nonconforming.

Event Description

A peritoneal dialysis (pd) patient (pt. ) presented to the hospital emergency room (er) on (b)(6) 2017 due to her pd drain not working properly, shortness of breath, orthopnea, and chest pain. As a result, the pt. Was admitted to the hospital that day for a breakdown (mechanical) of the intraperitoneal dialysis catheter. The pt. Had a hemodialysis (hd) catheter placed on (b)(6) 2017 and began daily in-patient hd for treatment of fluid volume overload improving the pt. ¿s chest pain. The pt. Was continued on daily in-patient hd in the hospital until (b)(6) 2017 with a net ultrafiltration of approximately 11. 5 liters (l). The pt. Did not receive dialysis on (b)(6) 2017 as the pt. Was being converted to thrice weekly hd in anticipation for discharge to a rehabilitation facility. On (b)(6) 2017, the pt. Was reportedly feeling much better; however, on (b)(6) 2017, the pt. Was symptomatically worse than the previous day. The pt. Was transferred to the dialysis unit at approximately noon on (b)(6) 2017 and had a critical potassium result of 6. 3. The pt. Began hd treatment to reportedly correct the electrolyte imbalance and within approximately 30 minutes of treatment, the pt. Displayed bradycardia and went into pulseless electrical activity (pea). As a result, cardiopulmonary resuscitation (cpr) was initiated and after one round of cpr (with administration of epinephrine), the pt. Regained a pulse. The pt. Was intubated and advanced cardiac life support (acls) was continued with administration of calcium, bicarbonate and levophed and dopamine drips in the intensive care unit (icu). The pt. Also received insulin/dextrose (d) 50 for hyperkalemia. However, the pt. Continued to arrest with multiple rounds of pea despite continued acls per protocol. Bedside echocardiogram revealed concerns of pulmonary embolism (pe) and as a result, the pt. Was also given clot dissolving tissue plasminogen activator (tpa) which briefly achieved return of spontaneous circulation (rosc). The pt. Continued to develop pea and despite multiple rounds of acls, the pt. Was not able to be resuscitated and was pronounced dead at 15:11. The pt. ¿s cause of death was cardiac arrest (cause unknown) with concomitant diagnoses significant for pulmonary hypertension, congestive heart failure, and acute respiratory failure (due to pulmonary edema versus pulmonary embolism). The hd machine and products used at the time of the pt. ¿s final hd treatment are unknown, however, the facility has a current account with fresenius medical care. There was no indication of any malfunction with any of the product(s) or device(s) in use during the hd treatment. However, no further information have been made available regarding the manufacturer of the products used during the pt's hd treatment on (b)(6) 2017.

• Brand Name: 2008K HEMODIALYSIS MACHINE
• 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. c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7017244
• MDR Text Key: 91749020
• Report Number: 2937457-2017-01167
• 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

• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 11/10/2017 Patient Sequence Number: 1