MAUDE Adverse Event Report: CONCORD MANUFACTURING DRY ACID 99; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	DRY ACID MIXER
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up will be submitted following evaluation.
Event or Problem Description
A facility technician reported a solenoid valve and harness were damage due to burnt valve and harness connector.The technician reported he did not see fire or smoke.The mixer was not operational.During follow up another facility contact reported there was no injury associated with the event and no patient involvement.The mixer was repaired on site.
Additional Manufacturer Narrative
Plant investigation: the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.
Event or Problem Description
".".

• Brand Name: DRY ACID 99
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 6885015
• Report Number: 2937457-2017-00937
• Device Sequence Number: 682663
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K911459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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 Model Number: DRY ACID MIXER
• Device Catalogue Number: 160148
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 09/21/2017
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1