MAUDE Adverse Event Report: CONCORD MANUFACTURING DRY ACID 99 GALLON UNIT, ASSY TO SHIP; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	160148
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Fire (1245)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A field service manager reported the clinic was mixing a batch of acid and the recirculation motor caught fire.The fire was put out with a fire extinguisher and structural damage to the tank was noted.Additional follow-up was made with the clinic manager, who confirmed there was no patient involvement and no harm or adverse event occurred as a result of the reported issue.No additional components were damaged, and emergency services were not needed.Per clinic manager it was unknown what may have attributed to the reported issue with the recirculation motor.The clinic manager confirmed that hospital grade ground-fault circuit interrupter (gfci) outlets were used.The previous mixer remained out of service since and no sample was available to be returned for evaluation.
Additional Manufacturer Narrative
Occupation: health care professional plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
Event or Problem Description
A field service manager reported the clinic was mixing a batch of acid and the recirculation motor caught fire.The fire was put out with a fire extinguisher and structural damage to the tank was noted.Additional follow-up was made with the clinic manager, who confirmed there was no patient involvement and no harm or adverse event occurred as a result of the reported issue.No additional components were damaged, and emergency services were not needed.Per clinic manager it was unknown what may have attributed to the reported issue with the recirculation motor.The clinic manager confirmed that hospital grade ground-fault circuit interrupter (gfci) outlets were used.The previous mixer remained out of service since and no sample was available to be returned for evaluation.
Additional Manufacturer Narrative
Plant investigation: the device was returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The reported problem that the recirculation pump motor caught fire was not duplicated during the investigation of the returned unit.During the initial inspection the unit was observed to have a ¿confined space¿ label.As per the installation instructions there should be 6¿ of space available on either side of the unit.An inspection of the unit display board found no physical damage/ burn damage.After replacing the burned wiring to the jet valve, the unit completed a rinse cycle in which the jet valve and recirculation pump motor functioned properly.Fluid leaks were observed during the rinse cycler coming from a hose connection in the hydraulic plumbing and from a recirculation pump hose connection.The burned damaged jet valve cable appears to have been resting in a build-up of concentrate from fluid leaks within the unit's hydraulics.The built-up concentrate shorted the cable leading to the observed burn damage.The jet valve connects to the display board through a cable.Neither the jet valve nor the display board had heat/burn damage and functioned properly during testing.The build-up of concentrate (salt deposits) and corrosion in the unit's hydraulics indicates the user was not making the recommended inspections.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
Event or Problem Description
A field service manager reported the clinic was mixing a batch of acid and the recirculation motor caught fire.The fire was put out with a fire extinguisher and structural damage to the tank was noted.Additional follow-up was made with the clinic manager, who confirmed there was no patient involvement and no harm or adverse event occurred as a result of the reported issue.No additional components were damaged, and emergency services were not needed.Per clinic manager it was unknown what may have attributed to the reported issue with the recirculation motor.The clinic manager confirmed that hospital grade ground-fault circuit interrupter (gfci) outlets were used.The previous mixer remained out of service since and no sample was available to be returned for evaluation.

• Brand Name: DRY ACID 99 GALLON UNIT, ASSY TO SHIP
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 6895493
• Report Number: 2937457-2017-00956
• Device Sequence Number: 761053
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2018

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: Health Professional
• Device Catalogue Number: 160148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Device Age: MO
• Initial Date Received by Manufacturer: 09/24/2017
• Supplement Date Received by Manufacturer: 01/02/2018; 02/15/2018
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 01/03/2018; 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1