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); Fire (1245); Melted (1385)

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

Event Date 01/01/2016

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 biomedical technician (biomed) at a user facility reported via a social media thread that valve 103 inside of a fresenius 2008t hemodialysis (hd) machine sustained corrosion and caught fire.The event occurred during testing six years prior to making the report.The biomed stated that the screws on the air separator loosened from the module expanding and contracting over time due to repeated heat disinfection cycles.The loosening on the air separator caused a leak onto valve 103 which led to corrosion and the resulting fire.The valve appeared charred, melted, and black.The biomed stated that the smoke detector was not triggered as a result of the fire caused by the burnt valve.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 biomed stated that valve 103, the valve block, and the bibag module were replaced to resolve the reported issue.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 biomedical technician (biomed) at a user facility reported via a social media thread that valve 103 inside of a fresenius 2008t hemodialysis (hd) machine sustained corrosion and caught fire.The event occurred during testing six years prior to making the report.The biomed stated that the screws on the air separator loosened from the module expanding and contracting over time due to repeated heat disinfection cycles.The loosening on the air separator caused a leak onto valve 103 which led to corrosion and the resulting fire.The valve appeared charred, melted, and black.The biomed stated that the smoke detector was not triggered as a result of the fire caused by the burnt valve.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 biomed stated that valve 103, the valve block, and the bibag module were replaced to resolve the reported issue.No parts are available to be returned to the manufacturer for physical evaluation.

Event Description

A biomedical technician (biomed) at a user facility reported via a social media thread that valve 103 inside of a fresenius 2008t hemodialysis (hd) machine sustained corrosion and caught fire.The event occurred during testing six years prior to making the report.The biomed stated that the screws on the air separator loosened from the module expanding and contracting over time due to repeated heat disinfection cycles.The loosening on the air separator caused a leak onto valve 103 which led to corrosion and the resulting fire.The valve appeared charred, melted, and black.The biomed stated that the smoke detector was not triggered as a result of the fire caused by the burnt valve.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 biomed stated that valve 103, the valve block, and the bibag module were replaced to resolve the reported issue.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.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13507461
• MDR Text Key: 285417117
• Report Number: 2937457-2022-00214
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• 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: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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