MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

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

Patient Problems Syncope (1610); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 03/16/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a temporal relationship exists between hd therapy with the 2008t hemodialysis machine and the patient¿s loss of consciousness, characterized by hypotension, bradycardia and syncope.However, the 2008t hemodialysis machine can be disassociated from these event(s), as there is no allegation or objective evidence a machine deficiency or malfunction was associated with these event(s).The patient experienced an episode of intradialytic hypotension and bradycardia during hd therapy, which led to a syncopial episode and subsequent loss of consciousness.Per the cn, the event(s) were unrelated to the functionality of the 2008t hemodialysis machine.The etiology stems from the intravascular volume changes which occur during ultrafiltration during hd therapy.Additionally, the 2008t hemodialysis machine passed all testing following the event(s).Intradialytic hypotension occurs in approximately 25% of all hd treatments, and is the most frequently observed complication of hd therapy.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) was hospitalized after experiencing a loss of consciousness during hd therapy.Follow-up with the outpatient dialysis center¿s charge nurse (cn) revealed the patient was complaining of ¿feeling bad¿ (specifics not provided) and became unresponsive approximately 2.5-hours into a 3.25-hour hd treatment.The cn stated the clinic staff was unable to locate a heartbeat and applied an automated external defibrillator (aed) which advised no shock.Cardiopulmonary resuscitation (cpr) was initiated (specifics not provided) and emergency medical services (ems) was contacted.The patient started to ¿come around¿ (specifics not provided) when ems arrived, and the patient was transported to the hospital.The discharge summary confirmed the patient received cpr at the outpatient dialysis clinic for what appeared to be pulseless electrical activity (pea).The patient arrived at the hospital alert and oriented x4, with a negative troponin (value not provided) level and normal labs (specifics not provided).Additionally, the patient underwent a chest x-ray, echocardiogram, electrocardiogram and nuclear stress test; all of which were unremarkable.The patient was given a syncopial workup which was negative, which provided evidence for the hospital to conclude the etiology of the event(s) was a syncopial episode of hypotension and bradycardia during hd therapy.The patient was discharged the following day in stable condition.Per the cn, the patient returned to the clinic on two days later for their regularly scheduled hd treatment, and received an additional treatment the following day to assist in further fluid removal.The patient has fully recovered from the event(s) and is doing well.The cn reported the event(s) were unrelated to a malfunction of the 2008t hd machine.Additionally, the bio-medical technician assessed the 2008t hd machine following the event(s) and no repairs were required.The 2008t machine passed all the required testing (specifics not provided), and the medical director returned the 2008t hd machine to service.

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 SYSTEM W/BIBAG
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8448030
• MDR Text Key: 139705448
• Report Number: 2937457-2019-00893
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 90