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

Model Number 191130

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

Patient Problems Dehydration (1807); Seizures (2063)

Event Date 07/31/2019

Event Type  Injury  

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.Clinical review: there is a temporal relationship between hemodialysis (hd) on the 2008t machine with the f40s steam sterilized dialyzer and unknown fmc bloodlines and the patient¿s seizure as they were in treatment at the time of the event.However, there is no documentation of a causal relationship between the fresenius products and the seizure.Additionally, there is no allegation of a machine malfunction or deficiency or reported defect with the dialyzer or blood lines reported for this event.The patient¿s seizure has been attributed to intravascular dehydration.A change in electrolyte balance can influence neuronal discharge causing alterations in brain metabolism.Based on the available information, the 2008t machine, dialyzer and blood lines can be excluded as the cause of the patient¿s adverse event; however, the hd treatment itself with shifts in fluid volume could have contributed to the already dehydrated patient status leading to the seizure.

Event Description

It was reported that a hemodialysis (hd) patient experienced a seizure during treatment at an hd clinic located within a hospital.The patient was approximately 2.5 hours into a regularly scheduled 4-hour treatment on the fresenius 2008t machine.The patient did not have any clear preceding event prior to the seizure.There were no noted machine issues and there were no observed issues with the dialyzer or blood lines.The patient was observed seizing and the code team was called to the chairside.The patient was administered oxygen and monitored until transported to the emergency department.The patient was admitted and diagnosed with a seizure.The cause of the seizure was initially reported as a febrile seizure; however, the nurse stated that the patient was on a school field trip in which it was thought they intravascularly dehydrated, despite an-above dry weight presentation, due to playing hard.The patient fully recovered within 24 hours with no long-term sequelae noted.Two days later he patient completed hd therapy in the hospital and then was discharged to home.The patient did have a history of one other seizure event in 2018 related to posterior reversible encephalopathy syndrome (pres).

Manufacturer Narrative

Correction: a4.

• Brand Name: 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
• 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: 8930923
• MDR Text Key: 155519199
• Report Number: 2937457-2019-02706
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (y/n): N
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 191130
• Device Catalogue Number: 191130
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS BLOODLINES; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 7 YR
• Patient Weight: 20