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 Problem Myocardial Infarction (1969)

Event Date 04/08/2023

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing a hospital provided 2008t hd system and the patient¿s mi leading to death.The cause of the patient¿s mi leading to death can be attributed to a significant cardiac disease history as reported by a medical professional.It is well known the 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.Therefore, the 2008t hd system can be excluded as a root cause or contributor to 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 events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

It was reported to fresenius by a hospital biomedical technician that the hemodialysis (hd) patient on in-center hd therapy expired during a dialysis treatment.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 the hospital hd registered nurse that cared for the patient, it was reported this patient expired due to a myocardial infarction (mi) during an hd treatment utilizing the 2008t hd system on 8/apr/2023 while hospitalized.The patient was initially admitted for a cardiac issue that directly caused fluid overload (admission date unknown).It was affirmed the patient¿s cardiac issue and fluid overload were unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient was given an hd treatment on (b)(6) 2023 with the 2008t hd system whereas the patient was normotensive throughout a majority of the treatment and gave no signs of distress.Approximately two and a half hours into the hd treatment, the patient leaned back in their chair and became unresponsive.The patient¿s blood pressure dropped to a systolic of 66 mmhg and continued to decline.The patient had a ¿do not resuscitate¿ order in place and life-saving measures were not conducted.Additionally, it was stated the patient initially requested hospice and to discontinue all modalities of renal replacement therapy upon admission, but their family would not allow this.It was confirmed the patient¿s myocardial infarction leading to his death was unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).

Event Description

It was reported to fresenius by a hospital biomedical technician that the hemodialysis (hd) patient on in-center hd therapy expired during a dialysis treatment.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 the hospital hd registered nurse that cared for the patient, it was reported this patient expired due to a myocardial infarction (mi) during an hd treatment utilizing the 2008t hd system on (b)(6) 2023 while hospitalized.The patient was initially admitted for a cardiac issue that directly caused fluid overload (admission date unknown).It was affirmed the patient¿s cardiac issue and fluid overload were unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient was given an hd treatment on (b)(6) 2023 with the 2008t hd system whereas the patient was normotensive throughout a majority of the treatment and gave no signs of distress.Approximately two and a half hours into the hd treatment, the patient leaned back in their chair and became unresponsive.The patient¿s blood pressure dropped to a systolic of 66 mmhg and continued to decline.The patient had a ¿do not resuscitate¿ order in place and life-saving measures were not conducted.Additionally, it was stated the patient initially requested hospice and to discontinue all modalities of renal replacement therapy upon admission, but their family would not allow this.It was confirmed the patient¿s myocardial infarction leading to their death was unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).A fresenius field service technician (fst) was called onsite following the event so a machine evaluation could be performed.The fst confirmed the machine was operated to manufacturer's specifications.

Manufacturer Narrative

Correction: b5 (information regarding onsite evaluation provided) 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.The investigation into the cause of the reported problem was not able to be confirmed.The complaint investigation did not find objective evidence indicating a product problem.

• 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: 16776476
• MDR Text Key: 313651286
• Report Number: 0002937457-2023-00587
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

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: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 05/16/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• 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): Death
• Patient Age: 89 YR
• Patient Sex: Male