MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG; HEMODIALYSIS SYSTEM FOR HOME USE

Model Number	190904
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
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
It was reported that a home patient on hemodialysis (hd) forgot to unclamp the heparin line prior to treatment initiation on a fresenius 2008k@home hd system.This resulted in the heparin pump encountering resistance when it was engaged.Furthermore, it was reported that a heparin pump alarm did not go off, and the patient's blood clotted.Upon follow-up, it was confirmed that the heparin pump alarm should have gone off.The patient elected to end their treatment and the entire circuit of blood was lost as a result.The estimated blood loss (ebl) was the equivalent of the quantity of blood held in a k@home single needle line set.The exact volume of blood lost was unknown.It was confirmed there were no adverse effects due to the blood loss, and no medical intervention was required.The machine was inspected the following morning by a field technician.The heparin pump was reportedly new.During testing, the technician confirmed that the heparin pump alarm did not go off.The technician then replaced the functional board and performed the test again.This time it alarmed appropriately.It was concluded that the functional board had failed to generate an alarm.There were no problems with the disposable supplies being used.The machine was tested thoroughly and returned to full functionality.As part of the testing, the technician administered a heparin bolus and held back the syringe plunger, and the machine alarmed appropriately.It was reported that the sample was available to be returned for evaluation.
Event or Problem Description
It was reported that a home patient on hemodialysis (hd) forgot to unclamp the heparin line prior to treatment initiation on a fresenius 2008k@home hd system.This resulted in the heparin pump encountering resistance when it was engaged.Furthermore, it was reported that a heparin pump alarm did not go off, and the patient's blood clotted.Upon follow-up, it was confirmed that the heparin pump alarm should have gone off.The patient elected to end their treatment and the entire circuit of blood was lost as a result.The estimated blood loss (ebl) was the equivalent of the quantity of blood held in a k@home single needle line set.The exact volume of blood lost was unknown.It was confirmed there were no adverse effects due to the blood loss, and no medical intervention was required.The machine was inspected the following morning by a field technician.The heparin pump was reportedly new.During testing, the technician confirmed that the heparin pump alarm did not go off.The technician then replaced the functional board and performed the test again.This time it alarmed appropriately.It was concluded that the functional board had failed to generate an alarm.There were no problems with the disposable supplies being used.The machine was tested thoroughly and returned to full functionality.As part of the testing, the technician administered a heparin bolus and held back the syringe plunger, and the machine alarmed appropriately.It was reported that the sample was available to be returned for evaluation.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received by the manufacturing plant for 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 investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.Should a sample be returned at a later date, a supplemental report will be submitted.

• Brand Name: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14047366
• Report Number: 2937457-2022-00594
• Device Sequence Number: 4907735
• Product Code: ONW
• UDI-Device Identifier: 00840861100965
• UDI-Public: 00840861100965
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K124035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022

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: 190904
• Device Catalogue Number: 190904
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 04/28/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Sex: Male