MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP; HEMODIALYSIS SYSTEM FOR HOME USE

Model Number	190395
Medical Device Problem Codes	Mechanical Problem (1384); Reflux within Device (1522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
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 (biomed) reported to fresenius technical services that a 2008k@home hemodialysis (hd) machine had a saline bag backfill while recirculating during set-up for use.The machine provided an audible alarm along with a ¿10 fill pgm in 1 hr¿ error message.A patient was not connected to the machine at the time of the incident.The biomed reported that the machine does not have the air separator adapter board installed.The fresenius technical support representative advised the biomed to install the air separator board and provided part information.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.
Event or Problem Description
A biomedical technician (biomed) reported to fresenius technical services that a 2008k@home hemodialysis (hd) machine had a saline bag backfill while recirculating during set-up for use.The machine provided an audible alarm along with a ¿10 fill pgm in 1 hr¿ error message.A patient was not connected to the machine at the time of the incident.The biomed reported that the machine does not have the air separator adapter board installed.The fresenius technical support representative advised the biomed to install the air separator board and provided part information.Additional information was requested however a response was not received.No parts were returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 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 did not determine a causal relationship between the objective evidence and the alleged event, therefore the reported issue is not confirmed.

• Brand Name: 2008K@HOME MACHINE,SHORT CAB,OLC/DP,HP
• Common Device Name: HEMODIALYSIS SYSTEM FOR HOME USE
• 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: 15076016
• Report Number: 0002937457-2022-01215
• Device Sequence Number: 4772952
• Product Code: ONW
• UDI-Device Identifier: 00840861100958
• UDI-Public: 00840861100958
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: Lay User/Patient
• Device Model Number: 190395
• Device Catalogue Number: 190395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2007
• 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