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

Model Number 190713

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

Patient Problems Cardiac Arrest (1762); Sepsis (2067)

Event Date 07/16/2022

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a temporal relationship between hemodialysis (hd) treatment utilizing the 2008t hd machine and the patient event of cardiopulmonary arrest.However, there is no documentation in the complaint file to show a causal relationship between the patient¿s cardiac event and the use of the 2008t hd machine.Additionally, there is no allegation of a machine malfunction or deficiency reported for this event.It was reported that the patient was in the icu for sepsis.Cardiac arrest is a known complication of patients with sepsis.Increasing age and pre-existing cardiac conditions increase the risk of cardiac arrest in these patients.The patient was documented to have pre-existing cardiac comorbidities (unspecified).Furthermore, the doctor and dialysis technician stated the adverse event were not related to use of the dialysis machine.The machine evaluation resulted in the passing of all functional testing.Based on the available information and no allegation or evidence of a malfunction or deficiency, the 2008t hd machine can be excluded as the cause of the patient¿s cardiopulmonary arrest.

Event Description

A biomedical technician reported that an evaluation was completed on a 2008t hemodialysis (hd) machine after an adverse event occurred.It was clarified that a patient experienced a cardiovascular event during treatment on the 2008t machine.The doctor and dialysis technician determined the event was not related to use of the machine.The patient was treated for the condition and the machine passed all required functional testing.Additional information was obtained through follow-up with the dialysis technician.This patient was in the intensive care unit (icu) for an admission of sepsis (admission date unknown).No information was provided related to the patient¿s hospitalization.Approximately 20 minutes into hd treatment on the 2008t machine, the patient went into cardiopulmonary arrest and a code blue was initiated.Cardiopulmonary resuscitation (cpr) was performed.It was unknown what additional interventions were provided during the arrest.It was reported that the patient has a history of cardiac conditions (unspecified).It was determined that neither the hd machine nor the hd treatment caused the patient¿s cardiopulmonary arrest.There were no issues with the hd treatment or machine prior to the event.The patient recovered from the arrest.The patient has completed multiple hd treatments since the adverse event without issue.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).The machine passed all functional testing during this evaluation including a series of uf checks used to evaluate uf removal.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 manufacturer was not able to determine a causal relationship between the objective evidence provided by the customer and the reported event.

Event Description

A biomedical technician reported that an evaluation was completed on a 2008t hemodialysis (hd) machine after an adverse event occurred.It was clarified that a patient experienced a cardiovascular event during treatment on the 2008t machine.The doctor and dialysis technician determined the event was not related to use of the machine.The patient was treated for the condition and the machine passed all required functional testing.Additional information was obtained through follow-up with the dialysis technician.This patient was in the intensive care unit (icu) for an admission of sepsis (admission date unknown).No information was provided related to the patient¿s hospitalization.Approximately 20 minutes into hd treatment on the 2008t machine, the patient went into cardiopulmonary arrest and a code blue was initiated.Cardiopulmonary resuscitation (cpr) was performed.It was unknown what additional interventions were provided during the arrest.It was reported that the patient has a history of cardiac conditions (unspecified).It was determined that neither the hd machine nor the hd treatment caused the patient¿s cardiopulmonary arrest.There were no issues with the hd treatment or machine prior to the event.The patient recovered from the arrest.The patient has completed multiple hd treatments since the adverse event without issue.

Manufacturer Narrative

Correction: b5 (clarification of initial reporter).

Event Description

A fresenius field service technician (fst) reported that an evaluation was completed on a 2008t hemodialysis (hd) machine after a user facility biomedical technician (biomed) reported that an adverse event had occurred.It was clarified that a patient experienced a cardiovascular event during treatment on the 2008t machine.The doctor and dialysis technician determined the event was not related to use of the machine.The patient was treated for the condition and the machine passed all required functional testing.Additional information was obtained through follow-up with the dialysis technician.This patient was in the intensive care unit (icu) for an admission of sepsis (admission date unknown).No information was provided related to the patient¿s hospitalization.Approximately 20 minutes into hd treatment on the 2008t machine, the patient went into cardiopulmonary arrest and a code blue was initiated.Cardiopulmonary resuscitation (cpr) was performed.It was unknown what additional interventions were provided during the arrest.It was reported that the patient has a history of cardiac conditions (unspecified).It was determined that neither the hd machine nor the hd treatment caused the patient¿s cardiopulmonary arrest.There were no issues with the hd treatment or machine prior to the event.The patient recovered from the arrest.The patient has completed multiple hd treatments since the adverse event without issue.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 15245436
• MDR Text Key: 298108693
• Report Number: 0002937457-2022-01371
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• 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,Followup
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• 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; Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male