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

Model Number 190766

Device Problems Thermal Decomposition of Device (1071); Electrical Shorting (2926)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

A user facility field service technician (fst) was called onsite to help repair a 2008t machine that experienced an art bp no comm.Message, a blood still sensed message, a valve 104/108 stuck closed message, and a 24 volt low message.The fst found bicarb had previously leaked down onto/inside the bibag hydraulic module and shorted several components.The fst replaced the bibag hydraulic module which corrected the v104/108 stuck closed message.However, the fst could not duplicate additional symptoms, suspect they may have been related to the shorted hydraulic module.Upon follow-up, the biomedical technician (bmt) stated there were three balance chamber components that appeared shorted and were replaced to resolve the reported issue.The machine is back in service.There was no patient involvement associated with the reported event.No sample or part is available to be returned for evaluation.

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 field service technician (fst) was called onsite to help repair a 2008t machine that experienced an art bp no comm.Message, a blood still sensed message, a valve 104/108 stuck closed message, and a 24 volt low message.The fst found bicarb had previously leaked down onto/inside the bibag hydraulic module and shorted several components.The fst replaced the bibag hydraulic module which corrected the v104/108 stuck closed message.However, the fst could not duplicate additional symptoms, suspect they may have been related to the shorted hydraulic module.Upon follow-up, the biomedical technician (bmt) stated there were three balance chamber components that appeared shorted and were replaced to resolve the reported issue.The machine is back in service.There was no patient involvement associated with the reported event.No sample or part is available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Investigation determines that there was causal relationship between the objective evidence and the alleged event; the alleged event 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.

Event Description

A user facility field service technician (fst) was called onsite to help repair a 2008t machine that experienced an art bp no comm.Message, a blood still sensed message, a valve 104/108 stuck closed message, and a 24 volt low message.The fst found bicarb had previously leaked down onto/inside the bibag hydraulic module and shorted several components.The fst replaced the bibag hydraulic module which corrected the v104/108 stuck closed message.However, the fst could not duplicate additional symptoms, suspect they may have been related to the shorted hydraulic module.Upon follow-up, the biomedical technician (bmt) stated there were three balance chamber components that appeared shorted and were replaced to resolve the reported issue.The machine is back in service.There was no patient involvement associated with the reported event.No sample or part is available to be returned for 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: 16417898
• MDR Text Key: 309973035
• Report Number: 0002937457-2023-00262
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2015
• 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