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 Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A biomedical technician at the user facility reported that a dry acid 99 machine has a burnt wiring harness connected to one of the valves.No patient was connected to the machine at the time of the incident.Therefore, no patient was involved.The current repair status of the unit is not known.Additional information has been requested, but has not been made available.No parts were available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res) and no parts were returned for failure analysis.The biomedical technician indicated that the wiring harness for the valve was burned.The current repair status of the unit is not known.It is not currently known if the unit has been returned to service at the user facility.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 during the manufacturing process which could be associated with 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.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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: 6661385
• Report Number: 2937457-2017-00495
• Device Sequence Number: 1601782
• Product Code: KPO
• UDI-Device Identifier: 00840861101009
• UDI-Public: 00840861101009
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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: Biomedical Engineer
• Device Catalogue Number: 160148
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1