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 Inadequate Ultra Filtration (1656)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

Note: please also see associated mdr (mfr report #: 2937457-2024-00683).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 support (ts) that a 2008t hemodialysis machine¿s ultrafiltration (uf) pump was not powering on/initiating when the treatment clock button was pressed on the display.The biomed stated there have not been any adverse reactions with patients, and the patients have continued treatment after the uf pump is initiated manually.The ts representative advised the biomed to check (and potentially swap) the functional board or actuator-test board.Additional details were provided upon follow-up with the biomed, and the charge nurse (cn) from the facility.The biomed and cn both confirmed that the machine¿s uf pump was not turning on automatically as it should have been.There were no machine alarms when this happened; however, the uf totals were flashing on the screen to alert the operator that the uf pump wasn¿t started.The biomed checked the machine¿s settings and found no differences when compared with other machines at the clinic.For some reason, this was the only machine with the issue.Once the uf pump was started, it functioned appropriately and removed the correct amount of fluid.The issue was that they had to manually press the button to get the uf started, which they don't have to do when they use their other machines.It was reported that this has happened during an unknown number of patient treatments, but there have not been any adverse events.The patients have not complained of any symptoms or experienced any adverse effects during or after their treatments.Event dates and all other treatment specific details could not be provided.The biomed replaced the functional board on the machine and it resolved the issue.The machine has been returned to service and the uf is now starting automatically.A sample was not available to be sent back for evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).However, the complaint investigation found objective evidence indicating a product problem, and thus the complaint was confirmed.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 reported event has been confirmed.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical support (ts) that a 2008t hemodialysis machine¿s ultrafiltration (uf) pump was not powering on/initiating when the treatment clock button was pressed on the display.The biomed stated there have not been any adverse reactions with patients, and the patients have continued treatment after the uf pump is initiated manually.The ts representative advised the biomed to check (and potentially swap) the functional board or actuator-test board.Additional details were provided upon follow-up with the biomed, and the charge nurse (cn) from the facility.The biomed and cn both confirmed that the machine¿s uf pump was not turning on automatically as it should have been.There were no machine alarms when this happened; however, the uf totals were flashing on the screen to alert the operator that the uf pump wasn¿t started.The biomed checked the machine¿s settings and found no differences when compared with other machines at the clinic.For some reason, this was the only machine with the issue.Once the uf pump was started, it functioned appropriately and removed the correct amount of fluid.The issue was that they had to manually press the button to get the uf started, which they don't have to do when they use their other machines.It was reported that this has happened during an unknown number of patient treatments, but there have not been any adverse events.The patients have not complained of any symptoms or experienced any adverse effects during or after their treatments.Event dates and all other treatment specific details could not be provided.The biomed replaced the functional board on the machine and it resolved the issue.The machine has been returned to service and the uf is now starting automatically.A sample was not available to be sent back for evaluation.

• 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: 19177018
• MDR Text Key: 341301963
• Report Number: 0002937457-2024-00684
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/03/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2017
• 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