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

Model Number 190904

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 290140285
• Report Number: 2937457-2022-00594
• Device Sequence Number: 1
• Product Code: ONW
• UDI-Device Identifier: 00840861100965
• UDI-Public: 00840861100965
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 190904
• Device Catalogue Number: 190904
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Sex: Male