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 Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 09/23/2022

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k2 hd device and the patient¿s cardiac arrest.The source of the patient¿s cardiac arrest cannot be determined; however, there was no indication this event was related to hd therapy or due to a deficiency or malfunction of any fresenius product(s) or device(s) as reported by a medical professional.It has been well established hd therapy carries a high risk of exacerbation of preexisting cardiac disease and sudden cardiac death.Therefore, the 2008k2 hd system can be excluded as root cause of this patient¿s adverse 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 patient¿s adverse event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported to fresenius that the patient experienced an arrest (stated as ¿coded¿ in the initial reporting) during acute hemodialysis (hd) therapy utilizing the 2008k2 dialysis system.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with a hospital hd registered nurse, it was reported this patient was initially hospitalized (exact date unknown) for respiratory failure requiring mechanical ventilation.The patient was not a chronic dialysis patient.The patient was placed on acute hd therapy for therapeutic effect during this admission following renal failure due to unspecified comorbidities, on a hospital-provided 2008k2 hd device.The patient began hd treatment on (b)(6) 2022 and approximately one hour into treatment, the patient experienced a cardiac arrest.The hospital cardiac arrest team arrived bedside and after multiple rounds of cardiopulmonary resuscitation, the patient had a return of systemic circulation.The patient remained in critical condition following the arrest and the decision was made by family to discontinue all modalities of therapeutic and life-saving measures as the patient was placed on a ¿comfort measures only¿ order.The patient expired in the afternoon of (b)(6) 2022 shortly after mechanical ventilation was discontinued.It was affirmed the patient was not on any modality of dialysis at the time of her death.Additionally, it was confirmed the patient¿s respiratory arrest, the associated hospitalization and cardiac arrest preempting their death were unrelated to renal replacement therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.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.It was determined that there is no causal relationship between the objective evidence and the alleged event.The investigation was not able to confirm the cause of the reported problem.

Event Description

It was reported to fresenius that the patient experienced an arrest (stated as ¿coded¿ in the initial reporting) during acute hemodialysis (hd) therapy utilizing the 2008k2 dialysis system.There was no specific allegation this event was due to a deficiency or malfunction of any fresenius product(s) or device(s) in the initial reporting.Upon follow up with a hospital hd registered nurse, it was reported this patient was initially hospitalized (exact date unknown) for respiratory failure requiring mechanical ventilation.The patient was not a chronic dialysis patient.The patient was placed on acute hd therapy for therapeutic effect during this admission following renal failure due to unspecified comorbidities, on a hospital-provided 2008k2 hd device.The patient began hd treatment on (b)(6) 2022 and approximately one hour into treatment, the patient experienced a cardiac arrest.The hospital cardiac arrest team arrived bedside and after multiple rounds of cardiopulmonary resuscitation, the patient had a return of systemic circulation.The patient remained in critical condition following the arrest and the decision was made by family to discontinue all modalities of therapeutic and life-saving measures as the patient was placed on a ¿comfort measures only¿ order.The patient expired in the afternoon on (b)(6) 2022 shortly after mechanical ventilation was discontinued.It was affirmed the patient was not on any modality of dialysis at the time of her death.Additionally, it was confirmed the patient¿s respiratory arrest, the associated hospitalization and cardiac arrest preempting their death were unrelated to renal replacement therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

• 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
• Manufacturer (Section G): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15671294
• MDR Text Key: 302393864
• Report Number: 0002937457-2022-01786
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• 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: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2009
• 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): Hospitalization; Death; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female