MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008T MACHINE

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

Patient Problems Cardiac Arrest (1762); Viral Infection (2248); Respiratory Failure (2484)

Event Date 09/27/2021

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 the patients death and hd therapy utilizing the 2008t hd machine.The cause of the patients death can be attributed to respiratory failure due to a covid-19 infection as reported by a medical professional.The end-stage renal disease (esrd) population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population, particularly in the environment of a covid-19 infection.Therefore, the 2008t hd machine can be excluded as a cause or contributor to this event.Based on the available information, there is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patients adverse events.

Event Description

A biomedical technician (biomed) from a hospital hemodialysis (hd) unit reported to fresenius technical support that a patient expired while undergoing an hd treatment.The biomed did not have any additional information (including a machine serial number) on the event.There was no specific allegation the event was due to a deficiency or malfunction of any fresenius product(s) or device(s).Additional information was obtained through follow up with a hospital hd registered nurse (hdrn) who was aware of the event.The hdrn confirmed the reported patient death.The patient expired during an hd treatment on a hospital provided 2008t hd machine while admitted for a covid-19 infection (admission date unknown).During the hospitalization, it was stated the patient went into severe respiratory failure due to the covid-19 infection and was placed on mechanical ventilation.The patients health declined over the hospital course and their death was determined to be imminent by hospital staff.The hospital staff responded to a cardiac arrest alert and the patient was provided lifesaving measures.Despite attempts to restore cardiac function, the patient expired due to respiratory failure caused by the covid-19 infection.The 2008t hd machine the patient was connected to at the time of their death underwent laboratory culture testing and functional testing.It was affirmed the 2008t hd machine passed all culture testing and functional checks conducted by a hospital biomedical technician.Additionally, it was confirmed the patients death due to severe respiratory failure, caused by a covid-19 infection, and the associated hospitalization were unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

Manufacturer Narrative

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. .

Event Description

A biomedical technician (biomed) from a hospital hemodialysis (hd) unit reported to fresenius technical support that a patient expired while undergoing an hd treatment.The biomed did not have any additional information (including a machine serial number) on the event.There was no specific allegation the event was due to a deficiency or malfunction of any fresenius product(s) or device(s).Additional information was obtained through follow up with a hospital hd registered nurse (hdrn) who was aware of the event.The hdrn confirmed the reported patient death.The patient expired during an hd treatment on a hospital provided 2008t hd machine while admitted for a covid-19 infection (admission date unknown).During the hospitalization, it was stated the patient went into severe respiratory failure due to the covid-19 infection and was placed on mechanical ventilation.The patient¿s health declined over the hospital course and their death was determined to be imminent by hospital staff.The hospital staff responded to a cardiac arrest alert and the patient was provided lifesaving measures.Despite attempts to restore cardiac function, the patient expired due to respiratory failure caused by the covid-19 infection.The 2008t hd machine the patient was connected to at the time of their death underwent laboratory culture testing and functional testing.It was affirmed the 2008t hd machine passed all culture testing and functional checks conducted by a hospital biomedical technician.Additionally, it was confirmed the patient¿s death due to severe respiratory failure, caused by a covid-19 infection, and the associated hospitalization were unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

• Brand Name: 2008T MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 12643508
• MDR Text Key: 276825026
• Report Number: 2937457-2021-02073
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention; Death
• Patient Sex: Male