MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

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

Patient Problems Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 10/13/2018

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: there is a temporal relationship between hd therapy on the 2008t machine and the patient event of cardiac arrest and subsequent death as the patient was in active treatment at the time of the event.However, there is no documentation to show a causal relationship between the machine and the event.Additionally, the biomed stated there is no allegation of any machine malfunction or deficiency and were required to report the event due to clinic policy.It is unknown what comorbidities the patient had that could have caused or contributed to the event.It is well known that sudden cardiac death accounts for 20-25% of all deaths in hemodialysis (jadoul et al, 2012).

Event Description

A user facility biomedical technician reported that a patient coded during hemodialysis (hd) treatment.Upon follow up, the clinical manager reported that the patient experienced hypotension and cardiac arrest and was transported to the hospital via emergency medical services.The patient subsequently passed away later that day on (b)(6) 2018.The clinical manager stated that the patient was a chronic dialysis patient and also suffered from diabetes.The clinical manager stated that there was no allegation of product deficiency or malfunction on or against the machine or any fresenius device(s).Additional information regarding the machine and the event was requested, however, not provided by the facility.

Manufacturer Narrative

The patient¿s blood pressure dropped at 1251 hours from 129/42 to 46/21.No carotid pulse or fistula thrill could be obtained.The patient was unresponsive and the treatment was ended.All blood was returned to the patient and he was placed in a trendelenburg position.The patient was bagged at 15l/100% and 500ml normal saline was given.The automated external defibrillator (aed) was brought to the bedside and cardiopulmonary resuscitation (cpr) was initiated.It is unknown if the aed was utilized.There was no return of spontaneous circulation (rosc).Emergency medical services (ems) were called and took over care once they arrived.The patient was transported via ems to the hospital where he subsequently expired (unknown time).Additional resuscitative efforts were not documented.The patient¿s total volume removed during treatment was 1163ml and a total of 500ml was infused.Per the biomedical technician there is no allegation of a machine malfunction.It is the clinic¿s policy to report a death during treatment.

Event Description

Additional clinical review: information in the complaint file and four pages of received treatment sheets were reviewed.On (b)(6) 2018, a hemodialysis clinic reported that a patient¿s blood pressures dropped (unknown value) and the patient went into cardiac arrest and then expired.Additional information was obtained through follow-up with the clinical manager on (b)(6) 2018 and the information in the treatment sheet.It was confirmed that this male patient on hemodialysis (hd) reported for a scheduled hd treatment on (b)(6) 2018.The patient¿s pre-dialysis vital signs were blood pressure (bp) 140/71, pulse 70, temp 98.4 and a start weight of (b)(6).Hd treatment was initiated at 1052 hours via left upper arm arteriovenous fistula utilizing the optiflux 180 nre.The blood flow was increased to the ordered rate of 400 with no issues.The patient¿s lines and needles were secured and taped.The patient denied any concerns at a 1230 hour safety check and while the technician was charting, the patient was noted to be slackjawed and pale at 1244.The tech was unable to arouse the patient and notified the nurse.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 8018709
• MDR Text Key: 125449183
• Report Number: 2937457-2018-03238
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 10/22/2018; 11/09/2018
• Supplement Dates FDA Received: 10/31/2018; 11/14/2018
• 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 Sequence Number: 1
• Treatment: FRESENIUS DIALYSIS CONCENTRATE; FRESENIUS DIALYZER
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 81