MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

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

Event Date 03/12/2024

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 biomedical technician (bmt) at a user facility reported a fresenius 2008t hemodialysis (hd) machine prompted with a bicarb pump no eos error message.The machine was opened and the bmt smelled something burnt.After checking the bicarb pump cable/connections and distribution board the bmt saw the connections were burnt and hard to remove and separate.The back of the distribution board at the bicarb connections had burnt marks and semi-melted.Both parts were replaced.There was no smoke, spark, or flame observed.There was no patient involvement or patient injury noted.Upon follow-up, the bmt confirmed the reported event and stated the issue occurred on (b)(6) 2024 and was noted during rinse mode of preventative maintenance.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 30,000 hours and the bicarb pump and distribution board were not the original fresenius parts on the machine.Per bmt the machine was repaired and is back in service without further issue.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.The bmt stated the bicarb pump and distribution board were no longer available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the product was not returned; a physical investigation could not be performed.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, the reported issue was confirmed due to burned connectors.

Event Description

A biomedical technician (bmt) at a user facility reported a fresenius 2008t hemodialysis (hd) machine prompted with a bicarb pump no eos error message.The machine was opened and the bmt smelled something burnt.After checking the bicarb pump cable/connections and distribution board the bmt saw the connections were burnt and hard to remove and separate.The back of the distribution board at the bicarb connections had burnt marks and semi-melted.Both parts were replaced.There was no smoke, spark, or flame observed.There was no patient involvement or patient injury noted.Upon follow-up, the bmt confirmed the reported event and stated the issue occurred on 03/12/2024 and was noted during rinse mode of preventative maintenance.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 30,000 hours and the bicarb pump and distribution board were not the original fresenius parts on the machine.Per bmt the machine was repaired and is back in service without further issue.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.The bmt stated the bicarb pump and distribution board were no longer available to be returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 18951419
• MDR Text Key: 338260944
• Report Number: 0002937457-2024-00484
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• 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: 04/23/2024

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: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 03/21/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2016
• 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