MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number 190895

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 02/14/2022

Event Type  Injury  

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-conformance's, 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

On 16/feb/2022, fresenius became aware this patient with acute kidney injury (aki) on hemodialysis (hd) for renal replacement therapy (rrt) ¿coded¿ during hd therapy, and later expired on 14/feb/2021.The patient was not undergoing rrt prior to admission to the hospital.Medical records indicate the patient was hospitalized on (b)(6)2022 for worsening bilateral lower extremity edema, chills, cellulitis, weight gain, and pain.An electrocardiogram (ekg) performed in the emergency room (er) was unremarkable for any acute processes (confirmed chronic atrial fibrillation), and a chest x-ray revealed increased vascular interstitial markings.The patient was deemed ¿fluid overloaded,¿ started on an intravenous (iv) lasix and nephrology/cardiology consults were ordered.Much of the hospitalization is unknown given the limited day-to-day detail, however the records show the patient was started on hemodialysis (hd) on (b)(6)2022 (2nd treatment on (b)(6)2022), after receiving a right intrajugular (ij) hd catheter (not a fresenius product).The patient was reportedly not responding to diuretic therapy and required increased ultrafiltration given her cardiac instability.On (b)(6)2022, the patient¿s pre-treatment vitals were within normal limits (blood pressure = 103/61, pulse = 68 bpm, respirations = 20, temperature = 98.0) and the patient¿s treatment was initiated at 8:25 am.The treatment record indicates at 8:46 am the patient¿s last recorded blood pressure was 83/48, with a heart rate of 48 bbm.Shortly following these measurements, the patient¿s blood pressure dropped (value not provided) and they became unresponsive.A ¿code blue¿ was called, the patient¿s blood was returned, and an additional 200 ml of normal saline was infused.Cardiopulmonary efforts were successful in reviving the patient, after which they were intubated and sent to the intensive care unit (icu) where they coded a second time.The patient¿s family arrived and given the patient¿s current condition, they agreed to a ¿do not resuscitate¿ (dnr) order.Subsequently at 5:45 pm, the patient coded a third time and was pronounced dead at 5:54 pm.The cause of death was reported as a cardiopulmonary arrest secondary to acute decompensated heart failure, bradycardia, liver cirrhosis, severe pulmonary hypertension, and aki.On (b)(6)2022, a bio-medical technician (bmt) was dispatched to perform post-event functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.A review of the follow-up testing revealed the 2008t hemodialysis system required recalibration of the uf pump.During post-event testing, the uf strokes were found to be above the allowable limit at 24.4 ml (allowable limits = 23.9 ¿ 24.1 ml) and was successfully recalibrated (elevated uf pump strokes would mean the 2008t hemodialysis system could potentially remove more fluid than what was programmed into the device).The remainder of the validation testing fell within manufacturer specifications.

Manufacturer Narrative

Correction: g2, h10 (clinical investigation) clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, and the adverse events of hypotension, bradycardia, loss of consciousness, and cardiopulmonary arrest which required the emergent discontinuation of hd therapy and initiation of emergency lifesaving measures.Per the medical records, causality was attributed to the patient¿s current cardiac condition (acute decompensated heart failure) due to atrial fibrillation, liver cirrhosis, pulmonary hypertension, and aki.The patient expired several hours after hd therapy was discontinued, however a dnr order was enacted prior to the event.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 contributory role in the patient¿s serious adverse events.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 occurred, and the uf pump required recalibration during post-event testing; this clinical investigation cannot disassociate the device from the serious adverse events.

Event Description

On (b)(6) 2022, fresenius became aware this patient with acute kidney injury (aki) on hemodialysis (hd) for renal replacement therapy (rrt) ¿coded¿ during hd therapy, and later expired on (b)(6) 2021.The patient was not undergoing rrt prior to admission to the hospital.Medical records indicate the patient was hospitalized on (b)(6) 2022 for worsening bilateral lower extremity edema, chills, cellulitis, weight gain, and pain.An electrocardiogram (ekg) performed in the emergency room (er) was unremarkable for any acute processes (confirmed chronic atrial fibrillation), and a chest x-ray revealed increased vascular interstitial markings.The patient was deemed ¿fluid overloaded,¿ started on an intravenous (iv) lasix and nephrology/cardiology consults were ordered.Much of the hospitalization is unknown given the limited day-to-day detail, however the records show the patient was started on hemodialysis (hd) on (b)(6) 2022 (2nd treatment on (b)(6) 2022), after receiving a right intrajugular (ij) hd catheter (not a fresenius product).The patient was reportedly not responding to diuretic therapy and required increased ultrafiltration given her cardiac instability.On (b)(6) 2022, the patient¿s pre-treatment vitals were within normal limits (blood pressure = 103/61, pulse = 68 bpm, respirations = 20, temperature = 98.0) and the patient¿s treatment was initiated at 8:25 am.The treatment record indicates at 8:46 am the patient¿s last recorded blood pressure was 83/48, with a heart rate of 48 bbm.Shortly following these measurements, the patient¿s blood pressure dropped (value not provided) and they became unresponsive.A ¿code blue¿ was called, the patient¿s blood was returned, and an additional 200 ml of normal saline was infused.Cardiopulmonary efforts were successful in reviving the patient, after which they were intubated and sent to the intensive care unit (icu) where they coded a second time.The patient¿s family arrived and given the patient¿s current condition, they agreed to a ¿do not resuscitate¿ (dnr) order.Subsequently at 5:45 pm, the patient coded a third time and was pronounced dead at 5:54 pm.The cause of death was reported as a cardiopulmonary arrest secondary to acute decompensated heart failure, bradycardia, liver cirrhosis, severe pulmonary hypertension, and aki.On (b)(6) 2022, a bio-medical technician (bmt) was dispatched to perform post-event functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.A review of the follow-up testing revealed the 2008t hemodialysis system required recalibration of the uf pump.During post-event testing, the uf strokes were found to be above the allowable limit at 24.4 ml (allowable limits = 23.9 ¿ 24.1 ml) and was successfully recalibrated (elevated uf pump strokes would mean the 2008t hemodialysis system could potentially remove more fluid than what was programmed into the device).The remainder of the validation testing fell within manufacturer specifications.

Manufacturer Narrative

Correction: h6 (health effect impact code).

Event Description

On (b)(6) 2022, fresenius became aware this patient with acute kidney injury (aki) on hemodialysis (hd) for renal replacement therapy (rrt) ¿coded¿ during hd therapy, and later expired on (b)(6) 2021.The patient was not undergoing rrt prior to admission to the hospital.Medical records indicate the patient was hospitalized on (b)(6) 2022 for worsening bilateral lower extremity edema, chills, cellulitis, weight gain, and pain.An electrocardiogram (ekg) performed in the emergency room (er) was unremarkable for any acute processes (confirmed chronic atrial fibrillation), and a chest x-ray revealed increased vascular interstitial markings.The patient was deemed ¿fluid overloaded,¿ started on an intravenous (iv) lasix and nephrology/cardiology consults were ordered.Much of the hospitalization is unknown given the limited day-to-day detail, however the records show the patient was started on hemodialysis (hd) on (b)(6) 2022 (2nd treatment on (b)(6) 2022), after receiving a right intrajugular (ij) hd catheter (not a fresenius product).The patient was reportedly not responding to diuretic therapy and required increased ultrafiltration given her cardiac instability.On (b)(6) 2022, the patient¿s pre-treatment vitals were within normal limits (blood pressure = 103/61, pulse = 68 bpm, respirations = 20, temperature = 98.0) and the patient¿s treatment was initiated at 8:25 am.The treatment record indicates at 8:46 am the patient¿s last recorded blood pressure was 83/48, with a heart rate of 48 bbm.Shortly following these measurements, the patient¿s blood pressure dropped (value not provided) and they became unresponsive.A ¿code blue¿ was called, the patient¿s blood was returned, and an additional 200 ml of normal saline was infused.Cardiopulmonary efforts were successful in reviving the patient, after which they were intubated and sent to the intensive care unit (icu) where they coded a second time.The patient¿s family arrived and given the patient¿s current condition, they agreed to a ¿do not resuscitate¿ (dnr) order.Subsequently at 5:45 pm, the patient coded a third time and was pronounced dead at 5:54 pm.The cause of death was reported as a cardiopulmonary arrest secondary to acute decompensated heart failure, bradycardia, liver cirrhosis, severe pulmonary hypertension, and aki.On 14/feb/2022, a bio-medical technician (bmt) was dispatched to perform post-event functional compliance and ultrafiltration (uf) testing on the 2008t hemodialysis system.A review of the follow-up testing revealed the 2008t hemodialysis system required recalibration of the uf pump.During post-event testing, the uf strokes were found to be above the allowable limit at 24.4 ml (allowable limits = 23.9 ¿ 24.1 ml) and was successfully recalibrated (elevated uf pump strokes would mean the 2008t hemodialysis system could potentially remove more fluid than what was programmed into the device).The remainder of the validation testing fell within manufacturer specifications.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• 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: 13709158
• MDR Text Key: 286845572
• Report Number: 2937457-2022-00361
• Device Sequence Number: 1
• Product Code: KPO
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• 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,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 190895
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 65 KG