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

Catalog Number UNKNOWN-2008K@HOME MACHINE

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

Patient Problem Death (1802)

Event Date 03/28/2020

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k@home hemodialysis (hd) system and the adverse event(s) of death.Although the patient completed hd therapy, she remained connected to the 2008k@home hd system when the event(s) occurred.There is no allegation, objective evidence or alarm history indicating a fresenius product(s) or device(s) deficiency or malfunction caused the patient¿s expiration.Nevertheless, based on the limited information available, causality cannot be firmly established.Documentation in the file, states the coroner determined the 2008k@home hd system or any fresenius products were ¿not at fault.¿ the esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.However, given the absence of a discharge summary, cause of death, autopsy report, death certificate and a pending manufacturer evaluation of the suspect device.The 2008k@home hd system cannot be excluded from having a possible contributory role in the patient¿s expiration, as there is insufficient evidence to conclude the root cause of the event(s).

Event Description

It was reported that a hemodialysis (hd) patient expired after completing hd therapy on a 2008k@home hd system.Initial reporting by the patient¿s home program head nurse (hphn) revealed the patient was re-infusing their blood (unknown if completed) when the event(s) occurred.The hphn stated a possible low blood pressure (hypotension) issue occurred and stated that an autopsy would need to be performed.Three pictures were provided of the 2008k@home hd system¿s screen.The pictures contained the blood pressure trends (date-range not provided), hd treatment data from the event date, and the service screen for the ultrafiltration (uf).The pictures showed a successfully completed 5 hour and 16-minute hd treatment (started at 22:09 and finished at 06:43).The patient¿s blood pressure at initiation of treatment was 101/57, with a heart rate (hr) of 80 bpm.The uf goal for the treatment was 3600 ml, and treatment data indicates the patient attained 3582 ml (a difference of 18 ml) of the programed uf.The patient received heparin during the treatment (dose not provided), the programed sodium was 140 meq/l, the blood flow rate was 270 ml/min, the dialysate flow rate was 300 ml/min and the concentrate used was h-401.At the completion of hd therapy, the patient¿s blood pressure was 134/76, with a hr of 90 bpm.In total, 26.0 liters of blood was processed, and no alarms were noted.During follow-up with the biomedical technician (bmt), it was reported the blood lines were discarded and unavailable for manufacturer evaluation.Additionally, while the coroner has determined a fresenius device(s) or product(s) was not ¿at fault,¿ the manufacturer evaluation of the suspect device and functional compliance testing is unavailable during this investigation.Multiple attempts were made to obtain additional information (e.G.Patient demographics, past medical history, concomitant medication list, discharge summary, autopsy report), however no further information was received.

Manufacturer Narrative

Correction: g3; the "foreign" source was inadvertently left unchecked on the initial report.Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 2008K@HOME MACHINE
• 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: 9972179
• MDR Text Key: 188031761
• Report Number: 2937457-2020-00689
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN-2008K@HOME MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death