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

Model Number 190766

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

Patient Problem Insufficient Information (4580)

Event Date 02/03/2022

Event Type  Death  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between hemodialysis therapy utilizing the fresenius 2008t machine and the patient event of coding with subsequent death.However, there is no documentation in the complaint file to show a causal relationship between use of the machine and the patient¿s adverse event.Although a cause of death had not been documented, the patient was described as frail, weak, and in declining health with suggestions from medical personnel to transition to hospice.The incidence of sudden cardiac death in hd patients is more than 50 times greater than in the general population and attributes for about a quarter of the total mortality of hd patients.The machine functional checks all passed, and no issues were encountered with the machine during treatment.Based on the available information and no allegation or evidence of a malfunction or deficiency, the fresenius 2008t machine can be excluded as the cause of the patient coding and subsequent death.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A biomedical technician (biomed) at a user facility reported that a hemodialysis (hd) patient coded on machine during treatment.The patient was sent to the hospital and passed away.There were no diagnostic messages or audible alarms.There was no reported problems with the treatment.Upon follow-up, the hd charge nurse reported this hd patient arrived for a regularly scheduled hd treatment.It was the patient¿s first hd treatment returning to the clinic since being discharged from the hospital for weakness (dates unknown).The patient was described as weak, frail, and in declining health.The doctors had been trying to get the patient¿s spouse to place the patient in hospice.The patient started a four-hour treatment in stable condition.The patient was noted as being very sleepy although able to be aroused.The patient¿s blood pressure (bp) was erratic (no values provided) during the treatment; however, this was normal for this patient.During the treatment, the patient was administered a normal saline fluid bolus (volume not provided) for low bp (value unknown).With approximately 28 minutes remaining in the four-hour treatment, the patient coded.The treatment was discontinued and 911 was called.Resuscitative efforts were performed.Prior to transport by emergency medical services (ems), the patient did have a pulse and blood pressure reading of 146/87; however, was not alert.The patient was transported at approximately 4:40pm to the hospital.The patient subsequently expired at the hospital at approximately 5:45pm.The cause of death has not been documented with the clinic.No further information was available as the patient¿s records have been closed out of the system.The nurse stated there were no issues with the 2008t machine or any dialysis products during the patient¿s treatment.The machine passed all functional checks as well as uf pump calibration and had since been returned to service.

Event Description

A biomedical technician (biomed) at a user facility reported that a hemodialysis (hd) patient coded on machine during treatment.The patient was sent to the hospital and passed away.There were no diagnostic messages or audible alarms.There was no reported problems with the treatment.Upon follow-up, the hd charge nurse reported this hd patient arrived for a regularly scheduled hd treatment.It was the patient¿s first hd treatment returning to the clinic since being discharged from the hospital for weakness (dates unknown).The patient was described as weak, frail, and in declining health.The doctors had been trying to get the patient¿s spouse to place the patient in hospice.The patient started a four-hour treatment in stable condition.The patient was noted as being very sleepy although able to be aroused.The patient¿s blood pressure (bp) was erratic (no values provided) during the treatment; however, this was normal for this patient.During the treatment, the patient was administered a normal saline fluid bolus (volume not provided) for low bp (value unknown).With approximately 28 minutes remaining in the four-hour treatment, the patient coded.The treatment was discontinued and 911 was called.Resuscitative efforts were performed.Prior to transport by emergency medical services (ems), the patient did have a pulse and blood pressure reading of 146/87; however, was not alert.The patient was transported at approximately 4:40pm to the hospital.The patient subsequently expired at the hospital at approximately 5:45pm.The cause of death has not been documented with the clinic.No further information was available as the patient¿s records have been closed out of the system.The nurse stated there were no issues with the 2008t machine or any dialysis products during the patient¿s treatment.The machine passed all functional checks as well as uf pump calibration and had since been returned to service.

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: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 13535643
• MDR Text Key: 285628936
• Report Number: 2937457-2022-00249
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2016
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male