MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190610

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

Patient Problem Cardiac Arrest (1762)

Event Date 08/16/2021

Event Type  Injury  

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 2008k2 hd machine and the patient¿s cardiac arrest.The source of the patient¿s cardiac arrest can be attributed to the patient¿s significant cardiac disease history as reported by a medical professional.It is well known 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 cardiac disease.Additionally, hd patients are at the highest risk for cardiac arrest with frequent occurrences in dialysis clinics.Therefore, the 2008k2 hd machine can be excluded as root cause of the patient¿s adverse event.Based on the required 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 patient¿s adverse event.

Event Description

A user facility biomedical technician (biomed) contacted fresenius technical support to ask about the tolerances for dialysate sample results from a 2008k2 hemodialysis (hd) machine.The biomed reported that a patient on hd therapy experienced a cardiac arrest during their hd treatment on the machine.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s).Upon follow up with the clinical manager (cm), it was confirmed the patient experienced a cardiac arrest during an in-center hd treatment.The patient became unresponsive within one minute of the initiation of the hd treatment.Cardiopulmonary resuscitation was initiated by clinic staff while emergency services were activated.The patient was transported to the hospital and had a return of systemic circulation.It was determined the patient¿s cardiac arrest was directly attributed to a significant history of cardiac disease.It was stated by the cm, considering the very short time the patient was on the hd machine, the hd treatment was ruled out as a source or contributor to the patient¿s cardiac arrest.The patient was able to undergo hd therapy on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2021.It was confirmed the patient¿s cardiac arrest, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd therapy on an in-center basis post-discharge.Additionally, it was reported the patient may be placed on hospice which would discontinue any modality of renal replacement therapy.The 2008k2 hd machine was inspected by the clinic biomedical technician and the machine passed all function checks.

Event Description

A user facility biomedical technician (biomed) contacted fresenius technical support to ask about the tolerances for dialysate sample results from a 2008k2 hemodialysis (hd) machine.The biomed reported that a patient on hd therapy experienced a cardiac arrest during their hd treatment on the machine.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s).Upon follow up with the clinical manager (cm), it was confirmed the patient experienced a cardiac arrest during an in-center hd treatment.The patient became unresponsive within one minute of the initiation of the hd treatment.Cardiopulmonary resuscitation was initiated by clinic staff while emergency services were activated.The patient was transported to the hospital and had a return of systemic circulation.It was determined the patient¿s cardiac arrest was directly attributed to a significant history of cardiac disease.It was stated by the cm, considering the very short time the patient was on the hd machine, the hd treatment was ruled out as a source or contributor to the patient¿s cardiac arrest.The patient was able to undergo hd therapy on a hospital provided hd machine (unknown brand and model) for the duration of the admission.The patient had an uneventful hospital course and was discharged to home on (b)(6) 2021.It was confirmed the patient¿s cardiac arrest, and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd therapy on an in-center basis post-discharge.Additionally, it was reported the patient may be placed on hospice which would discontinue any modality of renal replacement therapy.The 2008k2 hd machine was inspected by the clinic biomedical technician and the machine passed all function checks.

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: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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
• MDR Report Key: 12426055
• MDR Text Key: 270155626
• Report Number: 2937457-2021-01852
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• 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: 09/17/2021

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 Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 09/09/2021
• Supplement Dates FDA Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR