MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	190895
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A biomedical technician (biomed) reported that a hemodialysis (hd) machine was rinsed and in the processes of the rinse, a flow inlet error alarm occurred.The mandatory rinse mode completed without any flow error alarms and valve 103 hydrochamber outlet valve showed the black housing melted from the inside.The valve was replaced and the flow inlet error alarm was still present.The biomed was requested to have the bibag hydraulic assembly replaced.The part was ordered.Upon follow-up with the biomed, it was reported they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.The biomed confirmed the machine had 15,257.4 hours.The biomed stated that the replaced valve was the original fresenius part on the machine.The biomed stated the machine remains out of service pending replacement of the bibag hydraulic assembly.Additionally, the biomed confirmed there was no damage observed on any other components, or any other additional issues, associated with the melted valve.The biomed confirmed that 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 confirmed that the valve was discarded and is not available for return to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Correction: h6 investigation findings.
Event or Problem Description
A biomedical technician (biomed) reported that a hemodialysis (hd) machine was rinsed and in the processes of the rinse, a flow inlet error alarm occurred.The mandatory rinse mode completed without any flow error alarms and valve 103 hydrochamber outlet valve showed the black housing melted from the inside.The valve was replaced and the flow inlet error alarm was still present.The biomed was requested to have the bibag hydraulic assembly replaced.The part was ordered.Upon follow-up with the biomed, it was reported they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.The biomed confirmed the machine had 15,257.4 hours.The biomed stated that the replaced valve was the original fresenius part on the machine.The biomed stated the machine remains out of service pending replacement of the bibag hydraulic assembly.Additionally, the biomed confirmed there was no damage observed on any other components, or any other additional issues, associated with the melted valve.The biomed confirmed that 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 confirmed that the valve was discarded and is not available for return to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Correction: d9, g2, initial submission g3 should have been 07/01/2022.
Event or Problem Description
A biomedical technician (biomed) reported that a hemodialysis (hd) machine was rinsed and in the processes of the rinse, a flow inlet error alarm occurred.The mandatory rinse mode completed without any flow error alarms and valve 103 hydrochamber outlet valve showed the black housing melted from the inside.The valve was replaced and the flow inlet error alarm was still present.The biomed was requested to have the bibag hydraulic assembly replaced.The part was ordered.Upon follow-up with the biomed, it was reported they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.The biomed confirmed the machine had 15,257.4 hours.The biomed stated that the replaced valve was the original fresenius part on the machine.The biomed stated the machine remains out of service pending replacement of the bibag hydraulic assembly.Additionally, the biomed confirmed there was no damage observed on any other components, or any other additional issues, associated with the melted valve.The biomed confirmed that 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 confirmed that the valve was discarded and is not available for return to the manufacturer for physical evaluation.
Event or Problem Description
A biomedical technician (biomed) reported that a hemodialysis (hd) machine was rinsed and in the processes of the rinse, a flow inlet error alarm occurred.The mandatory rinse mode completed without any flow error alarms and valve 103 hydrochamber outlet valve showed the black housing melted from the inside.The valve was replaced and the flow inlet error alarm was still present.The biomed was requested to have the bibag hydraulic assembly replaced.The part was ordered.Upon follow-up with the biomed, it was reported they did not observe any burning smell, smoke, spark, flame, arcing, or any other visible heat or electrical damage related to the melting found on the valve.The biomed confirmed the machine had 15,257.4 hours.The biomed stated that the replaced valve was the original fresenius part on the machine.The biomed stated the machine remains out of service pending replacement of the bibag hydraulic assembly.Additionally, the biomed confirmed there was no damage observed on any other components, or any other additional issues, associated with the melted valve.The biomed confirmed that 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 confirmed that the valve was discarded and is not available for return to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).A physical investigation was not performed; the product was not returned.Investigation determines that there was causal relationship between the objective evidence (photo) and the alleged event; the alleged event is confirmed.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 confirm the reported failure mode.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• Common Device Name: 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: 14917487
• Report Number: 0002937457-2022-01116
• Device Sequence Number: 1881815
• Product Code: KDI
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/02/2022

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
• Operator of Device: Other
• Device Model Number: 190895
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 07/27/2022; 07/28/2022; 08/01/2022
• Initial Report FDA Received Date: 07/05/2022
• Supplement Report FDA Received Date: 07/27/2022; 08/01/2022; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown