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 Melted (1385)

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

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (bmt) reported to technical support that a 2008t machine gave an e.03: ram check error on power up.There was no patient involvement or patient injury noted.Upon follow-up, the bmt stated they replaced the power transformer to resolve the reported issue.The bmt stated the facility experienced an abrupt brownout which triggered the machine to prompt with an e.03: ram check error on power up.The bmt stated when evaluating the machine it was noted that the old power transformer appeared brown and melted.The bmt stated that there were no visible signs of smoke, flames, fire or sparks.It was confirmed there was no patient involved, harm or adverse events reported with this incident.The bmt confirmed 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 machine has approximately 21,000 hours and the transformer was original to the machine.The machine has not had any past problems with failing the electrical leakage test and there was no damage observed on any other components.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.Per bmt the transformer was functioning but was replaced as a precaution, and the machine remains in service without further issue.The bmt stated the transformer was available to be returned to the manufacturer for physical evaluation.

Event Description

A user facility biomedical technician (bmt) reported to technical support that a 2008t machine gave an e.03: ram check error on power up.There was no patient involvement or patient injury noted.Upon follow-up, the bmt stated they replaced the power transformer to resolve the reported issue.The bmt stated the facility experienced an abrupt brownout which triggered the machine to prompt with an e.03: ram check error on power up.The bmt stated when evaluating the machine it was noted that the old power transformer appeared brown and melted.The bmt stated that there were no visible signs of smoke, flames, fire or sparks.It was confirmed there was no patient involved, harm or adverse events reported with this incident.The bmt confirmed 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 machine has approximately 21,000 hours and the transformer was original to the machine.The machine has not had any past problems with failing the electrical leakage test and there was no damage observed on any other components.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.Per bmt the transformer was functioning but was replaced as a precaution, and the machine remains in service without further issue.The bmt stated the transformer was available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation found objective evidence indicating a product problem, thus the complaint is 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 investigation into the cause of the reported problem was able to be 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: 19097766
• MDR Text Key: 340805974
• Report Number: 0002937457-2024-00607
• 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: 05/21/2024

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: Other
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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