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

Model Number 190828

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

Clinical review: there is a temporal relationship between hd treatment utilizing the 2008k@home hemodialysis system and the patient suspected air embolism with transport to the local hospital.However, there is no documentation in the complaint file to show a causal relationship between use of the machine and the patient event.Additionally, the machine evaluation was completed, and no issues were found.An air embolism was not confirmed, and it is unknown if any medical intervention was received; however, based on the time the patient spent at the hospital it is likely the patient problem was not complex requiring invasive intervention.The patient has also returned to hd therapy utilizing the same machine without any further issues.The 2008k@home machine user¿s guide alerts the patient that the air detector alarm is a critical safety feature which will alert the user of potential air in the bloodline.The air detector will alert when the level of blood or saline in the venous drip chamber is too low.Failure to follow the instructions in the user¿s guide can result in serious injury or death.Based on the available information it is unknown if the patient experienced an adverse event with medical intervention.Additionally, the patient¿s machine evaluation did not find any machine issues and the patient has resumed treatment on the same machine.Therefore, the 2008k@home hemodialysis system can be excluded as causing the event with patient emergency transport to the local hospital.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported that a patient on hemodialysis (hd) utilizing the 2008k@home hemodialysis system was urgently hospitalized for a possible air embolism.The patient returned home four hours later.The machine was checked the following morning.The blood serum level in the venous chamber was 10mm above the level detector door; however, the patient reported that the level in the venous chamber was fine all the way until disconnect.The level calibration checked both channels and the calibrations were fine.The blood pump was found to have no problems.The machine passed all tests.No problems were found with the machine.Additional information confirmed the patient was 2 hours into a 3.5 hour hd treatment when an emergency was encountered.No signs or symptoms were reported.The patient reportedly disconnected from the machine per emergency disconnect procedures.The patient was transported to the hospital via emergency medical services (ems).It is unknown what testing or evaluation was completed at the hospital or if any medical intervention was received.The patient was discharged four hours after arrival.There is no confirmation that the patient was diagnosed with an air embolism.The patient reported no unusual alarms were received during the treatment and no foam was seen in the blood in the venous or arterial blood chamber.There were no level detector alarms.It is suspected the patient utilizes an arteriovenous (av) fistula as the hd access, but that was not confirmed.A photo documented that the level in the venous chamber was within normal limits.The patient has returned to hd therapy utilizing the same machine with no additional issues.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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
• 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: 9769296
• MDR Text Key: 181535703
• Report Number: 2937457-2020-00406
• Device Sequence Number: 1
• Product Code: ONW
• UDI-Device Identifier: 00840861100941
• UDI-Public: 00840861100941
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 190828
• Device Catalogue Number: 190828
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention