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 Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Loss of consciousness (2418)

Event Date 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, and the serious adverse event of loss of consciousness, which required the installation of iv normal saline and transportation to the hospital.The definitive cause of the serious adverse events is unknown; therefore, causality could not firmly be established.However, given the patient¿s positive response to volume repletion, the serious adverse events can be reasonably attributed to an episode intradialytic hypotension and/or hypovolemia.Intradialytic hypotension is the most prevalent complication associated with hd and occurs in approximately 25% of all treatments.Very often, the cause of intradialytic hypotension is multifactorial.Additionally, it should be noted that an elevated uf pump stroke could potentially remove more fluid from a patient than programed.Based on the information available, the 2008t hemodialysis system cannot be excluded from having a possible contributory role in the serious adverse events.There is currently no allegation a fresenius device(s) and/or product(s) deficiency or malfunction caused and/or contributed to the serious adverse events.However, given the patient was actively undergoing hd therapy when the events occurred, the uf pump requiring recalibration, and the lack of clinical follow-up, this clinical investigation cannot disassociate the device from the serious adverse events.It should be noted that a lack of clinical follow-up information precluded a more in-depth investigation.

Event Description

On 20/mar/2024, fresenius became aware this unknown patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a brief ¿loss of consciousness¿ during hd therapy on (b)(6) 2024.It was reported, the patient requested to discontinue hd therapy early (rationale not provided), after which the patient lost consciousness.The patient was given intravenous (iv) normal saline (volume not provided), and the patient regained consciousness.Following the event, the patient was transported to the hospital as a precaution, and as of (b)(6) 2024 the patient remained hospitalized.Post-event testing revealed the 2008t hemodialysis system required recalibration of the ultrafiltration (uf) pump, as it was found to be outside the manufacturer recommended specifications (allowable limits = 23.9 ¿ 24.1 ml) by 0.10 ml/stroke or 24.2 ml.Aside from the out-of-range uf pump, there were no other device alarms reported.Subsequent attempts to obtain additional information (e.G., treatment record, uf checklist, functionality testing, machine repair logs, patient demographics) were unsuccessful.

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.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.

Event Description

On 20/mar/2024, fresenius became aware this unknown patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) experienced a brief ¿loss of consciousness¿ during hd therapy on (b)(6) 2024.It was reported, the patient requested to discontinue hd therapy early (rationale not provided), after which the patient lost consciousness.The patient was given intravenous (iv) normal saline (volume not provided), and the patient regained consciousness.Following the event, the patient was transported to the hospital as a precaution, and as of (b)(6) 2024 the patient remained hospitalized.Post-event testing revealed the 2008t hemodialysis system required recalibration of the ultrafiltration (uf) pump, as it was found to be outside the manufacturer recommended specifications (allowable limits = 23.9 ¿ 24.1 ml) by 0.10 ml/stroke or 24.2 ml.Aside from the out-of-range uf pump, there were no other device alarms reported.Subsequent attempts to obtain additional information (e.G., treatment record, uf checklist, functionality testing, machine repair logs, patient demographics) were unsuccessful.

• 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: 19085763
• MDR Text Key: 339878362
• Report Number: 0002937457-2024-00596
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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: 03/20/2024
• Initial Date FDA Received: 04/11/2024
• 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: 05/05/2017
• 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
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening