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 Seizures (2063); Loss of consciousness (2418)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship exists between hd therapy utilizing the 2008t hemodialysis machine and the patient¿s loss of consciousness, which warranted hospitalization.However, the 2008t hemodialysis machine can be disassociated from these events, as there is no allegation or objective evidence indicating a fresenius product deficiency or malfunction was associated with these events.The patient experienced a seizure during hd therapy on (b)(6) 2019, which led to a loss of consciousness.Per the cm, the events were unrelated to the utilization or functionality of the 2008t hemodialysis machine.The cm reported causality is attributed to a newly diagnosed seizure disorder.Additionally, the 2008t hemodialysis machine passed all functional compliance testing post event and was found to be operating within manufacturer specifications.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

An fst (field service technician) was called onsite by a user facility to repair a 2008t machine with a reported evaluation of functional checks for 2008t.The 2008t hemodialysis machine was found to be functioning as intended, per the manufacturer¿s specifications.Following the testing, the 2008t hemodialysis machine was returned to service.The fst reported that the patient lost consciousness and was transferred to a hospital.Upon follow up the clinic¿s manager (cm) reported the patient experienced a seizure (specifics not provided) during dialysis and lost consciousness (specifics not provided).The hd treatment was discontinued, the patient¿s blood was returned and emergency medical services (ems) was called.The patient regained consciousness (specifics not provided) shortly after discontinuing the hd treatment, and ems transported the patient to the hospital for evaluation.At the hospital, the patient was diagnosed with a newly discovered seizure disorder (specifics not provided), and the patient was placed on medication (drug, dose, frequency not provided).The patient was discharged home (date not provided) in stable condition and continues to undergo hd therapy without issue.The cm reported the patient recovered from the event and has not suffered another seizure since.The discharge summary, treatment data, patient demographics, past medical history and medication list were requested; however, the request was declined.The cm stated the patient¿s loss of consciousness was unrelated to hd therapy or any fresenius product(s) or device(s), despite it occurring during hd therapy.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A user facility requested an evaluation of a 2008t machine.A fresenius field service technician (fst) performed an on-site device evaluation and confirmed the 2008t machine functions as designed.The machine passed functional testing and was returned to service.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: 9214119
• MDR Text Key: 163053456
• Report Number: 2937457-2019-03216
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR