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 Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 06/02/2022

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 hypotension, bradycardia, loss of consciousness, cardiac arrest, and death which required the emergent discontinuation of hd therapy and initiation of emergency lifesaving measures.Per the medical records, the definitive cause of the serious adverse events is unknown; however, the patient was known to have multiple cardiac conditions and was a non-surgical candidate for stenting.Per the cn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.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.Of these deaths, cardiovascular disease and/or sudden cardiac death is the leading cause.Based on the information available, the 2008t hemodialysis system cannot be excluded from having a possible causal or contributory role in the serious adverse events.There is currently no allegation 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 occurred, in addition to the uf pump requiring recalibration during post-event testing.This clinical investigation cannot disassociate the device from the serious adverse events.

Event Description

It was reported a peritoneal dialysis (pd) patient ¿coded¿ during treatment, and later expired on 2/jun/2022.Medical records and follow-up with the patient¿s charge nurse (cn) revealed the patient arrived at the outpatient hemodialysis (hd) center for his scheduled (1st at this clinic) hd treatment.The patient was in stable condition and was recently discharged from the hospital on 31/may/2022 after being treated for multiple cardiac disorders and subsequently requiring rrt as a result.The patient¿s pre-treatment vitals included a blood pressure (b/p) = 116/74, heart rate = 64, respirations = 18, temperature = 98.0, and hd therapy began at 13:53 (b/p = 129/63, heart rate = 65).The patient¿s treatment progressed without incident until 15:58 when the extracorporeal circuit clotted.The patient¿s hd treatment was restarted (exact time not provided) and at 16:32 it was discovered the patient was hypotensive (b/p = 97/38, heart rate = 51, o2sat = 76%), apneic, and could not be aroused.Cardiopulmonary resuscitative measures (cpr) were started at 16:33, which included normal saline administration, oxygenation, compressions, and the application of an automated external defibrillator (aed) at 16:35.Emergency medical services (ems) were contacted at 16:40, and while awaiting ems, the aed defibrillated the patient four times (16:38, 16:41, 16:43 and 16:56), however no pulse could be obtained.Ems arrived at 17:04 and intubated the patient, established an access, and administered 3 doses of epinephrine prior to transporting the patient to the hospital at 17:10.The patient¿s vitals prior to leaving the outpatient clinic included a b/p of 168/117 and a heart rate of 107.The patient reportedly went into venous fibrillation during transport and was given several emergency medications as well as being shocked a fifth time.Upon arrival to the hospital the patient underwent multiple rounds of emergency lifesaving measures (e.G., medication, defibrillation, cpr, oxygenation) without success and was pronounced dead at 18:01.The preliminary cause of death was listed as cardiac arrest, and no autopsy was performed.Per the cn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.On 2/jun/2022, a fresenius field service technician (fst) was dispatched to perform post-event functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.A review of the testing revealed the 2008t hemodialysis system required recalibration of the uf pump, as it was found to be outside (value not provided) of manufacturer recommended specification (allowable limits = 23.9 ¿ 24.1 ml) and was successfully recalibrated.The remainder of the validation testing fell within manufacturer specifications and the machine was returned to service.The 'uf problem identification checklist' was received on 10/jun/2022.The document confirmed the uf pump required stroke recalibration (performed on 6/jun/2022).The manufacturer specifications state the uf pump stroke value should be 24.0 ml/stroke, with an allowable variance of 0.996-1.004 ml.When post-event verification testing was performed, the value was 24.6 ml/stroke.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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 issue was confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.The cause code and annex codes were selected because the ultrafiltration pump required calibration to meet manufacturer recommended specification.

Event Description

It was reported a peritoneal dialysis (pd) patient ¿coded¿ during treatment, and later expired on (b)(6) 2022.Medical records and follow-up with the patient¿s charge nurse (cn) revealed the patient arrived at the outpatient hemodialysis (hd) center for his scheduled (1st at this clinic) hd treatment.The patient was in stable condition and was recently discharged from the hospital on (b)(6) 2022 after being treated for multiple cardiac disorders and subsequently requiring rrt as a result.The patient¿s pre-treatment vitals included a blood pressure (b/p) = 116/74, heart rate = 64, respirations = 18, temperature = 98.0, and hd therapy began at 13:53 (b/p = 129/63, heart rate = 65).The patient¿s treatment progressed without incident until 15:58 when the extracorporeal circuit clotted.The patient¿s hd treatment was restarted (exact time not provided) and at 16:32 it was discovered the patient was hypotensive (b/p = 97/38, heart rate = 51, o2sat = 76%), apneic, and could not be aroused.Cardiopulmonary resuscitative measures (cpr) were started at 16:33, which included normal saline administration, oxygenation, compressions, and the application of an automated external defibrillator (aed) at 16:35.Emergency medical services (ems) were contacted at 16:40, and while awaiting ems, the aed defibrillated the patient four times (16:38, 16:41, 16:43 and 16:56), however no pulse could be obtained.Ems arrived at 17:04 and intubated the patient, established an access, and administered 3 doses of epinephrine prior to transporting the patient to the hospital at 17:10.The patient¿s vitals prior to leaving the outpatient clinic included a b/p of 168/117 and a heart rate of 107.The patient reportedly went into venous fibrillation during transport and was given several emergency medications as well as being shocked a fifth time.Upon arrival to the hospital the patient underwent multiple rounds of emergency lifesaving measures (e.G., medication, defibrillation, cpr, oxygenation) without success and was pronounced dead at 18:01.The preliminary cause of death was listed as cardiac arrest, and no autopsy was performed.Per the cn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.On (b)(6) 2022, a fresenius field service technician (fst) was dispatched to perform post-event functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.A review of the testing revealed the 2008t hemodialysis system required recalibration of the uf pump, as it was found to be outside (value not provided) of manufacturer recommended specification (allowable limits = 23.9 ¿ 24.1 ml) and was successfully recalibrated.The remainder of the validation testing fell within manufacturer specifications and the machine was returned to service.The 'uf problem identification checklist' was received on (b)(6) 2022.The document confirmed the uf pump required stroke recalibration (performed on (b)(6) 2022).The manufacturer specifications state the uf pump stroke value should be 24.0 ml/stroke, with an allowable variance of 0.996-1.004 ml.When post-event verification testing was performed, the value was 24.6 ml/stroke.

Event Description

It was reported a peritoneal dialysis (pd) patient ¿coded¿ during treatment, and later expired on 2/jun/2022.Medical records and follow-up with the patient¿s charge nurse (cn) revealed the patient arrived at the outpatient hemodialysis (hd) center for his scheduled (1st at this clinic) hd treatment.The patient was in stable condition and was recently discharged from the hospital on (b)(6) 2022 after being treated for multiple cardiac disorders and subsequently requiring rrt as a result.The patient¿s pre-treatment vitals included a blood pressure (b/p) = 116/74, heart rate = 64, respirations = 18, temperature = 98.0, and hd therapy began at 13:53 (b/p = 129/63, heart rate = 65).The patient¿s treatment progressed without incident until 15:58 when the extracorporeal circuit clotted.The patient¿s hd treatment was restarted (exact time not provided) and at 16:32 it was discovered the patient was hypotensive (b/p = 97/38, heart rate = 51, o2sat = 76%), apneic, and could not be aroused.Cardiopulmonary resuscitative measures (cpr) were started at 16:33, which included normal saline administration, oxygenation, compressions, and the application of an automated external defibrillator (aed) at 16:35.Emergency medical services (ems) were contacted at 16:40, and while awaiting ems, the aed defibrillated the patient four times (16:38, 16:41, 16:43 and 16:56), however no pulse could be obtained.Ems arrived at 17:04 and intubated the patient, established an access, and administered 3 doses of epinephrine prior to transporting the patient to the hospital at 17:10.The patient¿s vitals prior to leaving the outpatient clinic included a b/p of 168/117 and a heart rate of 107.The patient reportedly went into venous fibrillation during transport and was given several emergency medications as well as being shocked a fifth time.Upon arrival to the hospital the patient underwent multiple rounds of emergency lifesaving measures (e.G., medication, defibrillation, cpr, oxygenation) without success and was pronounced dead at 18:01.The preliminary cause of death was listed as cardiac arrest, and no autopsy was performed.Per the cn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.On (b)(6) 2022, a fresenius field service technician (fst) was dispatched to perform post-event functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.A review of the testing revealed the 2008t hemodialysis system required recalibration of the uf pump, as it was found to be outside (value not provided) of manufacturer recommended specification (allowable limits = 23.9 ¿ 24.1 ml) and was successfully recalibrated.The remainder of the validation testing fell within manufacturer specifications and the machine was returned to service.The 'uf problem identification checklist' was received on 10/jun/2022.The document confirmed the uf pump required stroke recalibration (performed on (b)(6) 2022).The manufacturer specifications state the uf pump stroke value should be 24.0 ml/stroke, with an allowable variance of 0.996-1.004 ml.When post-event verification testing was performed, the value was 24.6 ml/stroke.

Manufacturer Narrative

Correction: h6 investigation conclusions, h10 plant investigation plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).Investigation determines that there was causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.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.

• 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: 14683112
• MDR Text Key: 293911194
• Report Number: 0002937457-2022-00956
• 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,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/25/2022

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: Other
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 06/22/2022; 09/23/2022
• Supplement Dates FDA Received: 06/23/2022; 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• 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
• Treatment: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Outcome(s): Hospitalization; Death; Life Threatening; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 108 KG