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 Problems Apnea (1720); Cyanosis (1798); Loss of consciousness (2418)

Event Date 06/12/2021

Event Type  Death  

Manufacturer Narrative

Plant investigation: 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 2008t hemodialysis system, and the adverse events of apnea, cyanosis, and loss of consciousness, which required the emergent discontinuation of hd therapy and initiation of emergency lifesaving measures.The definitive cause of the patients adverse events is unknown; therefore, causality cannot firmly be established.However, per the cm, the patient suffered from advanced heart failure and recent diagnostic testing revealed the patients ejection fraction was 15% (non-surgical candidate).The patients cardiac status was discussed with the patients family; however, the decision was made to continue incenter hd therapy despite objections from the nephrologist and cardiologist.The esrd population continues to have significantly higher mortality (up to 30-fold higher), and fewer expected years of life when compared to the general population.Once hospitalized, the patient was made dnr/cmo, and the patient subsequently expired later the same day.Hospice care is defined as a medical intervention, with the expected outcome being the patient will expire as a result.Based on the totality of the information available, the 2008t hemodialysis system cannot be excluded from having a possible causal and/or contributory role in the patients serious adverse events and subsequent death.At this time there is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused and/or contributed to the events.However, given the patient was actively undergoing hd therapy when the events began, and the uf pump required recalibration during post-event testing; this clinical investigation cannot disassociate the device from the serious adverse events.

Event Description

It was reported that a hemodialysis (hd) patient coded during treatment and expired after treatment was complete and while hospitalized.The biomedical technician stated that the machine passed all tests post treatment, except for the ultrafiltration (uf) volume.The uf volume was 23.6 ml from 24 strokes, however the lower allowable limit is 23.9 ml.Upon follow-up, the clinic manager (cm) confirmed the patient expired on (b)(6) 2021.The cm stated the patient suffered from advanced heart failure and both the nephrologist and cardiologist requested the family discontinue renal replacement therapy (rrt) due to the patients poor cardiac status.Recent diagnostic testing revealed the patients cardiac output was severely diminished (ejection fraction = 15%, non-surgical candidate), and the patients medical care team was concerned hemodialysis (hd) would strain the patients heart too much.The family declined and requested the patient continue to be dialyzed incenter.The cm stated although the patients death was unexpected it was not a surprise given the recent findings regarding the patients cardiac status.The machine was reportedly sequestered following the events and passed all post-event functional compliance testing [the cm was aware of ultrafiltration (uf) pump out of range].A careful review of the medical records provided revealed the patient arrived for her regularly scheduled treatment in stable condition.The patients pre-treatment vitals were within normal limits (blood pressure = 179/45, pulse = 51, respirations = 18, temperature = 98.2) and the patients treatment was initiated at 12:24.The treatment record indicates at 12:54 the patient required the installation of cathflo to achieve adequate blood flow.The cathflo installation was successful, and the patients treatment was restarted at 13:42 with a blood flow rate (bfr) of 300 ml/min.At 14:35 the patient was found to be agonal breathing, they let out a long exhale, and their respirations ceased.Cardiopulmonary pulmonary resuscitation (cpr) was initiated, and emergency medical services (ems) was contacted.An automated external defibrillator (aed) was applied to the patient, however no shock was advised and the user facility staff continued to perform cpr until ems arrived at 14:50.The patient remained unresponsive and was intubated prior to arriving at the er at 15:40.Once at the hospital, numerous radiological and hematological studies were performed, and at 16:15 the patients family arrived and were informed of the patients condition.The patient required a ventilator to breathe, vasopressors for blood pressure support (hypotensive) and was tachycardic (110-130s).The family agreed to a do not resuscitate (dnr) order, and to provide comfort measures only (cmo).The patient was given ativan and morphine, extubated, and pronounced dead at 17:02 due to cardiopulmonary arrest.The 2008t hemodialysis system was sequestered following the events, and a review of the uf problem identification checklist revealed the 2008t hemodialysis system required recalibration of the uf pump.During post-event compliance testing, the uf pump stroke was below the allowable limit at 0.987 ml/stroke (allowable limits = 0.996  1.004 ml/stroke) and was successfully recalibrated.(low uf pump strokes would mean the 2008t hemodialysis system could potentially remove less fluid then what was programmed into the device).The remainder of the validation testing fell within manufacturer specifications, and the 2008t hemodialysis system was returned to service.

Event Description

It was reported that a hemodialysis (hd) patient coded during treatment and expired after treatment was complete and while hospitalized.The biomedical technician stated that the machine passed all tests post treatment, except for the ultrafiltration (uf) volume.The uf volume was 23.6 ml from 24 strokes, however the lower allowable limit is 23.9 ml.Upon follow-up, the clinic manager (cm) confirmed the patient expired on (b)(6) 2021.The cm stated the patient suffered from advanced heart failure and both the nephrologist and cardiologist requested the family discontinue renal replacement therapy (rrt) due to the patient¿s poor cardiac status.Recent diagnostic testing revealed the patient¿s cardiac output was severely diminished (ejection fraction= 15%, non-surgical candidate), and the patient¿s medical care team was concerned hemodialysis (hd) would ¿strain the patient¿s heart too much.¿ the family declined and requested the patient continue to be dialyzed incenter.The cm stated although the patient¿s death was unexpected it was not a surprise given the recent findings regarding the patient¿s cardiac status.The machine was reportedly sequestered following the events and passed all post-event functional compliance testing [the cm was aware of ultrafiltration (uf) pump out of range].A careful review of the medical records provided revealed the patient arrived for her regularly scheduled treatment in stable condition.The patient¿s pre-treatment vitals were within normal limits (blood pressure= 179/45, pulse= 51, respirations= 18, temperature= 98.2) and the patient¿s treatment was initiated at 12:24.The treatment record indicates at 12:54 the patient required the installation of cathflo to achieve adequate blood flow.The cathflo installation was successful, and the patient¿s treatment was restarted at 13:42 with a blood flow rate (bfr) of 300 ml/min.At 14:35 the patient was found to be agonal breathing, they let out a ¿long exhale,¿ and their respirations ceased.Cardiopulmonary pulmonary resuscitation (cpr) was initiated, and emergency medical services (ems) was contacted.An automated external defibrillator (aed) was applied to the patient, however ¿no shock¿ was advised and the user facility staff continued to perform cpr until ems arrived at 14:50.The patient remained unresponsive and was intubated prior to arriving at the er at 15:40.Once at the hospital, numerous radiological and hematological studies were performed, and at 16:15 the patient¿s family arrived and were informed of the patient¿s condition.The patient required a ventilator to breathe, vasopressors for blood pressure support (hypotensive) and was tachycardic (110-130¿s).The family agreed to a ¿do not resuscitate¿ (dnr) order, and to provide comfort measures only (cmo).The patient was given ativan and morphine, extubated, and pronounced dead at 17:02 due to cardiopulmonary arrest.The 2008t hemodialysis system was sequestered following the events, and a review of the ¿uf problem identification checklist¿ revealed the 2008t hemodialysis system required recalibration of the uf pump.During post-event compliance testing, the uf pump stroke was below the allowable limit at 0.987 ml/stroke (allowable limits= 0.996 ¿ 1.004 ml/stroke) and was successfully recalibrated.(low uf pump strokes would mean the 2008t hemodialysis system could potentially remove less fluid then what was programmed into the device).The remainder of the validation testing fell within manufacturer specifications, and the 2008t hemodialysis system was returned to service.

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.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.

Event Description

It was reported that a hemodialysis (hd) patient coded during treatment and expired after treatment was complete and while hospitalized.The biomedical technician stated that the machine passed all tests post treatment, except for the ultrafiltration (uf) volume.The uf volume was 23.6 ml from 24 strokes, however the lower allowable limit is 23.9 ml.Upon follow-up, the clinic manager (cm) confirmed the patient expired on (b)(6) 2021.The cm stated the patient suffered from advanced heart failure and both the nephrologist and cardiologist requested the family discontinue renal replacement therapy (rrt) due to the patient¿s poor cardiac status.Recent diagnostic testing revealed the patient¿s cardiac output was severely diminished (ejection fraction = 15%, non-surgical candidate), and the patient¿s medical care team was concerned hemodialysis (hd) would ¿strain the patient¿s heart too much.¿ the family declined and requested the patient continue to be dialyzed incenter.The cm stated although the patient¿s death was unexpected it was not a surprise given the recent findings regarding the patient¿s cardiac status.The machine was reportedly sequestered following the events and passed all post-event functional compliance testing [the cm was aware of ultrafiltration (uf) pump out of range].A careful review of the medical records provided revealed the patient arrived for her regularly scheduled treatment in stable condition.The patient¿s pre-treatment vitals were within normal limits (blood pressure = 179/45, pulse = 51, respirations = 18, temperature = 98.2) and the patient¿s treatment was initiated at 12:24.The treatment record indicates at 12:54 the patient required the installation of cathflo to achieve adequate blood flow.The cathflo installation was successful, and the patient¿s treatment was restarted at 13:42 with a blood flow rate (bfr) of 300 ml/min.At 14:35 the patient was found to be agonal breathing, they let out a ¿long exhale,¿ and their respirations ceased.Cardiopulmonary pulmonary resuscitation (cpr) was initiated, and emergency medical services (ems) was contacted.An automated external defibrillator (aed) was applied to the patient, however ¿no shock¿ was advised and the user facility staff continued to perform cpr until ems arrived at 14:50.The patient remained unresponsive and was intubated prior to arriving at the er at 15:40.Once at the hospital, numerous radiological and hematological studies were performed, and at 16:15 the patient¿s family arrived and were informed of the patient¿s condition.The patient required a ventilator to breathe, vasopressors for blood pressure support (hypotensive) and was tachycardic (110-130¿s).The family agreed to a ¿do not resuscitate¿ (dnr) order, and to provide comfort measures only (cmo).The patient was given ativan and morphine, extubated, and pronounced dead at 17:02 due to cardiopulmonary arrest.The 2008t hemodialysis system was sequestered following the events, and a review of the ¿uf problem identification checklist¿ revealed the 2008t hemodialysis system required recalibration of the uf pump.During post-event compliance testing, the uf pump stroke was below the allowable limit at 0.987 ml/stroke (allowable limits = 0.996 ¿ 1.004 ml/stroke) and was successfully recalibrated.(low uf pump strokes would mean the 2008t hemodialysis system could potentially remove less fluid then what was programmed into the device).The remainder of the validation testing fell within manufacturer specifications, and the 2008t hemodialysis system was returned to service.

Manufacturer Narrative

Correction: g2, h6 type of investigation.

• 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
• MDR Report Key: 12084142
• MDR Text Key: 258908499
• Report Number: 2937457-2021-01347
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2021

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: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 06/30/2021; 07/07/2021
• Supplement Dates FDA Received: 06/30/2021; 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 87 YR
• Patient Weight: 59