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 Sparking (2595)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility¿s biomedical technician (biomed) reported that during heat disinfection mode, a fresenius 2008t hemodialysis (hd) machine sparked at the outlet and resulted in a gray, burnt power cord.The machine alarmed appropriately and powered down.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The power cord was not the original fresenius part on the machine, but it was a fresenius part.The part number was not available.The biomed reported that there was no melting, burning smell, smoke, flame, or arcing observed.The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine has approximately 2,400 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the power cord, which resolved the issue.The biomed reported that the machine has been returned to service without issue.The power cord was reported to be available to be returned to the manufacturer for physical evaluation.

Event Description

A user facility¿s biomedical technician (biomed) reported that during heat disinfection mode, a fresenius 2008t hemodialysis (hd) machine sparked at the outlet and resulted in a gray, burnt power cord.The machine alarmed appropriately and powered down.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The power cord was not the original fresenius part on the machine, but it was a fresenius part.The part number was not available.The biomed reported that there was no melting, burning smell, smoke, flame, or arcing observed.The biomed reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine has approximately 2,400 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the power cord, which resolved the issue.The biomed reported that the machine has been returned to service without issue.The power cord was not returned to the manufacturer for physical 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).The manufacturer was able to determine a causal relationship between the objective evidence provided by the customer and the reported event.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.

• 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: 18904547
• MDR Text Key: 337747717
• Report Number: 0002937457-2024-00436
• 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
• Report Date: 04/15/2024

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: 03/12/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/12/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2012
• 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