MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problems Mechanical Problem (1384); Reflux within Device (1522)

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

Event Date 04/01/2023

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported to fresenius that a saline bag backfill issue occurred with a 2008t hemodialysis (hd) machine.The reported issue occurred during setup outside of clinic hours.There was no patient involvement.The reported issue was visually observed.There were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed stated that the serial number and software revision of the machine were provided to technical support who recommended that the air separator board be replaced.The air separator board was replaced to resolve the reported issue.A software update was not required following replacement of the air separator board.The machine is back in service without reoccurrence of the reported event.No parts are available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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 a saline bag backfill issue occurred with a 2008t hemodialysis (hd) machine.The reported issue occurred during setup outside of clinic hours.There was no patient involvement.The reported issue was visually observed.There were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed stated that the serial number and software revision of the machine were provided to technical support who recommended that the air separator board be replaced.The air separator board was replaced to resolve the reported issue.A software update was not required following replacement of the air separator board.The machine is back in service without reoccurrence of the reported event.No parts are available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Correction: d4 (serial number), h4.

Event Description

A user facility biomedical technician (biomed) reported to fresenius that a saline bag backfill issue occurred with a 2008t hemodialysis (hd) machine.The reported issue occurred during setup outside of clinic hours.There was no patient involvement.The reported issue was visually observed.There were no quick disconnects on the drain line and that the drain line length and height were within specification.The biomed stated that the serial number and software revision of the machine were provided to technical support who recommended that the air separator board be replaced.The air separator board was replaced to resolve the reported issue.A software update was not required following replacement of the air separator board.The machine is back in service without reoccurrence of the reported event.No parts are available to be returned to the manufacturer for physical evaluation.

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.Objective evidence was found during the manufacturer investigation indicating a product problem, thus the complaint is confirmed.

• 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: 16777028
• MDR Text Key: 313730582
• Report Number: 0002937457-2023-00590
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2023

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 Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 04/20/2023; 05/03/2023
• Supplement Dates FDA Received: 04/20/2023; 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2012
• 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