MAUDE Adverse Event Report: CONCORD MANUFACTURING DISSOLUTION UNIT-TESTED; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number G047-80101

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

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

Event Date 07/21/2021

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 user facility biomedical technician (bmt) reported to technical support that a 132 gallon dry acid mixer caught on fire.There was no damage to the building or no other damage was noted.There was no patient involvement with the reported event.Additional information was requested and was not received to date.

Manufacturer Narrative

Plant investigation: a physical investigation cannot be performed since the product was not returned, no further actions can be performed.The reported event was confirmed by the fresenius field technician (fst) and provided photos.A product history 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 complaint was able to confirm the reported event.

Event Description

A user facility biomedical technician (bmt) reported to technical support that a 132 gallon dry acid mixer caught on fire.There was no damage to the building or no other damage was noted.There was no patient involvement with the reported event.A fresenius fst (field service technician) was then called onsite by a user facility to to perform a preliminary assessment for fire damage to a 132 gallon dry acid mixer with a reported fire contained to the mixer motor.The fst reported extinguisher residue was present on the mixer.The biomedical technician stated the staff saw flames.There was no patient involvement, no harm, or adverse event reported.Additional information was requested and was not received to date.

Event Description

A user facility biomedical technician (bmt) reported to technical support that a 132 gallon dry acid mixer caught on fire.There was no damage to the building or no other damage was noted.There was no patient involvement with the reported event.A fresenius fst (field service technician) was then called onsite by a user facility to perform a preliminary assessment for fire damage to a 132 gallon dry acid mixer with a reported fire contained to the mixer motor.The fst reported extinguisher residue was present on the mixer.The biomedical technician stated the staff saw flames.There was no patient involvement, no harm, or adverse event reported.Additional information was requested and was not received to date.

Manufacturer Narrative

Additional information: b5.

Event Description

A user facility biomedical technician (bmt) reported to technical support that a 132 gallon dry acid mixer caught on fire.There was no damage to the building or no other damage was noted.There was no patient involvement with the reported event.Additional information was requested and was not received to date.

Manufacturer Narrative

Correction: d5; g2 health professional changed from "yes" to "no"; g2 company representative changed from "no" to "yes"; h6 medical device problem code.

• Brand Name: DISSOLUTION UNIT-TESTED
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 12298381
• MDR Text Key: 265755016
• Report Number: 2937457-2021-01657
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• PMA/PMN Number: K911459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/30/2021

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: G047-80101
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/18/2021; 08/18/2021; 08/27/2021
• Supplement Dates FDA Received: 08/19/2021; 08/20/2021; 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1