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 Problem Loss of consciousness (2418)

Event Date 03/07/2024

Event Type  Injury  

Manufacturer Narrative

Clinical review: it was confirmed the patient¿s loc due to a cardiac arrhythmia, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).Based on the provided information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue.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 that the hemodialysis (hd) patient experienced an adverse event approximately 13 seconds after treatment initiation on the 2008t machine and required medical intervention.The biomed confirmed that the patient did not pass away.Upon follow up with the patient¿s hd registered nurse, it was reported this patient experienced loss of consciousness (loc) at the beginning of an hd treatment in the in-center clinic on (b)(6) 2024.It was explained the patient¿s loc was attributed to a preexisting cardiac arrhythmia that has caused fainting in the past while not on hd therapy.It was believed that the patient would have fainted whether they were on the machine or not and it was determined the patient¿s loc was completely unrelated to the hd treatment.The patient had loc shortly after the needle was placed into their arteriovenous access and before blood ran through the 2008t hd system.The treatment was immediately stopped, and emergency services were activated.It was affirmed that there was no blood loss involved with this event.The patient regained consciousness shortly after and they were transported to the hospital by emergency services.The patient was admitted to the hospital on the same day and diagnosed with an exacerbation of a cardiac arrhythmia.The patient was able to undergo hd therapy on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.The patient recovered from this event and continues hd therapy on an in-center basis post-discharge.

Event Description

A user facility biomedical technician (biomed) reported to fresenius that the hemodialysis (hd) patient experienced an adverse event approximately 13 seconds after treatment initiation on the 2008t machine and required medical intervention.The biomed confirmed that the patient did not pass away.Upon follow up with the patient¿s hd registered nurse, it was reported this patient experienced loss of consciousness (loc) at the beginning of an hd treatment in the in-center clinic on (b)(6) 2024.It was explained the patient¿s loc was attributed to a preexisting cardiac arrhythmia that has caused fainting in the past while not on hd therapy.It was believed that the patient would have fainted whether they were on the machine or not and it was determined the patient¿s loc was completely unrelated to the hd treatment.The patient had loc shortly after the needle was placed into their arteriovenous access and before blood ran through the 2008t hd system.The treatment was immediately stopped, and emergency services were activated.It was affirmed that there was no blood loss involved with this event.The patient regained consciousness shortly after and they were transported to the hospital by emergency services.The patient was admitted to the hospital on the same day and diagnosed with an exacerbation of a cardiac arrhythmia.The patient was able to undergo hd therapy on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2024.The patient recovered from this event and continues hd therapy on an in-center basis post-discharge.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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; 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: 18987872
• MDR Text Key: 338726212
• Report Number: 0002937457-2024-00519
• 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: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 121 KG