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

Catalog Number	190395
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/10/2023
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 home hemodialysis (hd) patient reported they forgot to unclamp the heparin line during their treatment on a fresenius 2008k@home machine, and the machine failed to alarm.The incident resulted in blood loss due to blood within the system coagulating after four hours of treatment.The patient¿s estimated blood loss (ebl) was approximately 180 ml.Upon follow-up with the field service technician (fst) familiar with the event, it was indicated that use error was possibly involved.When the technician tested the heparin pump, it was confirmed that the machine alarmed appropriately.Although the patient forgot to unclamp the heparin line, the technician stated that the machine should have produced a heparin pump alarm.It was confirmed that the patient was using the heparin pump for the treatment.The technician stated there was no bolus delivery set up, but the heparin pump settings were reportedly set properly.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.
Additional Manufacturer Narrative
Correction: g2 plant investigation: no parts were returned to the manufacturer for physical evaluation.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 complaint investigation did not find objective evidence indicating a product problem, and thus the complaint was not confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
A home hemodialysis (hd) patient reported they forgot to unclamp the heparin line during their treatment on a fresenius 2008k@home machine, and the machine failed to alarm.The incident resulted in blood loss due to blood within the system coagulating after four hours of treatment.The patient¿s estimated blood loss (ebl) was approximately 180 ml.Upon follow-up with the field service technician (fst) familiar with the event, it was indicated that use error was possibly involved.When the technician tested the heparin pump, it was confirmed that the machine alarmed appropriately.Although the patient forgot to unclamp the heparin line, the technician stated that the machine should have produced a heparin pump alarm.It was confirmed that the patient was using the heparin pump for the treatment.The technician stated there was no bolus delivery set up, but the heparin pump settings were reportedly set properly.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.

• 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: 18000010
• Report Number: 0002937457-2023-01609
• Device Sequence Number: 17970608
• Product Code: ONW
• UDI-Device Identifier: 00840861100958
• UDI-Public: 00840861100958
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2023

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 Catalogue Number: 190395
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2007
• 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: Male