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 Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2020

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 hemodialysis (hd) patient experienced blood loss during treatment.The venous transducer line reportedly filled with blood at the beginning of the treatment.After replacing the dialyzer with a new one, the blood pump was restarted.Several alarms occurred and additional blood pump restarts were performed.Eventually, a noticeable amount of air became visible in the bloodstream (within the venous transducer line).The patient contacted the on-call nurse and emergency medical services (ems) was called.There was no indication that the patient developed any symptoms or experienced any adverse effects.The event resulted in blood loss of an unspecified volume.It was reported that the blood loss amount was the equivalent of the fill volume for the closed circuit.Upon arrival, ems evaluated the patient and found no abnormalities.The patient did not require any medical intervention as a result of the event.The patient has resumed hd treatment in-center and will then transition to the home training program.An evaluation of the hd machine did not find any issues.Unrelated to the reported issue, the pump rotor was replaced due to the lever being hard to open.There was no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.No sample is expected to be returned for manufacturer evaluation.

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 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.

• 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
• MDR Report Key: 10818244
• MDR Text Key: 216127961
• Report Number: 2937457-2020-02037
• Device Sequence Number: 1
• Product Code: ONW
• UDI-Device Identifier: 00840861100965
• UDI-Public: 00840861100965
• Combination Product (y/n): N
• PMA/PMN Number: K124035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1