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 Chest Pain (1776); Dyspnea (1816)

Event Date 11/19/2021

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 2008 hd machine and the patient¿s chest pain and dyspnea.The cause of the patient¿s symptoms cannot be determined; however, it was confirmed this event was not due to a deficiency or malfunction of any fresenius product(s) or device(s) by a medical professional.It is well known hd patients may experience acute complications associated with multi-comorbidity and/or the patient¿s physiological response to normal hd therapy.Therefore, the 2008 hd machine 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.

Event Description

It was reported to fresenius technical support (ts) that a hemodialysis (hd) patient experienced a cardiac arrest during hd treatment.The user facility requested onsite service from a fresenius field service technician (fst) to evaluate the 2008 hd machine that was being utilized.Upon follow up with the patient¿s hd registered nurse, it was reported this patient experienced chest pain and shortness of breath during an hd treatment.The patient developed symptoms approximately 30 minutes after the initiation of hd and the treatment was discontinued.The patient was provided oxygen and blood was returned to the patient.Emergency services were activated, and the patient was transported to the emergency department (ed) of a local hospital.It was found the patient did not experience a cardiac arrest and did not require medical intervention beyond oxygen administration.The patient was found to be negative for a cardiac event as an electrocardiogram and laboratory tests taken in the ed resulted in normal cardiac function.The patient was released to home from the ed with no hospital admission.The cause of the patient¿s symptoms was unknown; however, they were ruled out for a dialyzer reaction or any other adverse event relating to the hd treatment.Additionally, it was confirmed the patient¿s dyspnea, chest pain, and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd on an in-center basis following this event.The fst confirmed the 2008 hd machine was operating properly.No issues were found during functional testing of the machine.

Event Description

It was reported to fresenius technical support (ts) that a hemodialysis (hd) patient experienced a cardiac arrest during hd treatment.The user facility requested onsite service from a fresenius field service technician (fst) to evaluate the 2008t hd machine that was being utilized.Upon follow up with the patient¿s hd registered nurse, it was reported this patient experienced chest pain and shortness of breath during an hd treatment.The patient developed symptoms approximately 30 minutes after the initiation of hd and the treatment was discontinued.The patient was provided oxygen and blood was returned to the patient.Emergency services were activated, and the patient was transported to the emergency department (ed) of a local hospital.It was found the patient did not experience a cardiac arrest and did not require medical intervention beyond oxygen administration.The patient was found to be negative for a cardiac event as an electrocardiogram and laboratory tests taken in the ed resulted in normal cardiac function.The patient was released to home from the ed with no hospital admission.The cause of the patient¿s symptoms was unknown; however, they were ruled out for a dialyzer reaction or any other adverse event relating to the hd treatment.Additionally, it was confirmed the patient¿s dyspnea, chest pain, and the associated ed visit were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd on an in-center basis following this event.The fst confirmed the 2008t hd machine was operating properly.No issues were found during functional testing of the machine.

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 fst concluded that the 2008t hemodialysis (hd) machine was operating properly.No issues were found during functional testing.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.Based on the machine inspection performed by the fst, the cause of the reported problem was not able to be confirmed.The machine passed all functional testing and was confirmed to be working as expected.

• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12911279
• MDR Text Key: 284003455
• Report Number: 2937457-2021-02376
• 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: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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: 12/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2012
• 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
• Patient Sex: Male