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

Catalog Number 191126

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

Patient Problem Convulsion/Seizure (4406)

Event Date 01/01/2024

Event Type  Injury  

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that a patient experienced a seizure during hemodialysis (hd) treatment on the 2008t machine.The biomed did not have other information available upon initial reporting.An onsite evaluation was requested before the machine was returned to service.Additional information was requested however a response was not provided.The service record from the field service technician (fst) indicates the ultrafiltration (uf) pump was low @ 0.88 ml, which was recalibrated to 1.0 ml (manufacturer specifications are 0.9 to 1.1 ml).The 2008t hemodialysis system seemed to run perfectly in dialysis mode, however the machine failed all self-test checks except the 9-volt battery, conductivity, temperature, and blood leak detector.Upon inspecting the debug screen, the fst noted valve 43 was in the open position and never closed.The air separator sensor read a constant ¿air,¿ when there should be no air present when the machine is up in conductivity.Therefore, the machine failed the pressure holding test, and most of the alarm tests.The fst discovered on the distribution board that air sensor cable # 6 was not securely connected.The fst reseated the air sensor cable on the distribution board and the air signal changed to ¿no air,¿ and valve 43 closed.All self-tests were performed a total of (b)(4) and passed each time.The fst could not explain why this sensor was partially unplugged, but it was the root cause of the machine failing its self-test.Lastly, the fst reviewed the machine's history and found no component hydraulic service was ever performed on this machine, only pressure checks.

Manufacturer Narrative

Clinical review: a temporal relationship exists between hd therapy utilizing a 2008t hemodialysis system, and the patient¿s serious adverse event of a seizure.The definitive etiology of the seizure is unknown; therefore, causality cannot be established.Per the documentation provided, the fst¿s service record revealed valve 43 was open, allowing air to be sensed by the air detector.This occurred due to sensor cable # 6 becoming dislodged; however, the cause of the disconnection is also unknown.Limited follow-up information precluded a more comprehensive clinical investigation.Seizures are not uncommon among patients on hemodialysis.There are many potential causes of seizures among patients on hemodialysis.In most circumstances, seizure activity occurs during or shortly after the hemodialysis procedure because of the hemodynamic and biochemical changes associated with the process.Other examples could include: uremic encephalopathy, dialysis disequilibrium syndrome, or drug induced causes.Based on the limited information available, the 2008t hemodialysis system cannot be disassociated from the serious adverse event.During intake, there was no allegation a fresenius device(s) and/or product(s) caused and/or contributed to the serious adverse event.However, given the findings during post-event functional compliance testing, the lack of patient demographics, hospital records and/or treatment records; there is insufficient evidence for this clinical investigation to exclude the 2008t hemodialysis system from having a possible role in the serious adverse event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that a patient experienced a seizure during hemodialysis (hd) treatment on the 2008t machine.The biomed did not have other information available upon initial reporting.An onsite evaluation was requested before the machine was returned to service.Additional information was requested however a response was not provided.The service record from the field service technician (fst) indicates the ultrafiltration (uf) pump was low @ 0.88 ml, which was recalibrated to 1.0 ml (manufacturer specifications are 0.9 to 1.1 ml).The 2008t hemodialysis system seemed to run perfectly in dialysis mode, however the machine failed all self-test checks except the 9-volt battery, conductivity, temperature, and blood leak detector.Upon inspecting the debug screen, the fst noted valve 43 was in the open position and never closed.The air separator sensor read a constant ¿air,¿ when there should be no air present when the machine is up in conductivity.Therefore, the machine failed the pressure holding test, and most of the alarm tests.The fst discovered on the distribution board that air sensor cable # 6 was not securely connected.The fst reseated the air sensor cable on the distribution board and the air signal changed to ¿no air,¿ and valve 43 closed.All self-tests were performed a total of three times and passed each time.The fst could not explain why this sensor was partially unplugged, but it was the root cause of the machine failing its self-test.Lastly, the fst reviewed the machine's history and found no component hydraulic service was ever performed on this machine, only pressure checks.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.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 complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18574584
• MDR Text Key: 333658339
• Report Number: 0002937457-2024-00140
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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: 191126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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
• Patient Outcome(s): Required Intervention