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 Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)

Event Date 08/31/2022

Event Type  Injury  

Event Description

A biomedical technician (bmt) reported to fresenius technical services this hemodialysis (hd) patient on in-center hd therapy experienced a cardiac arrest (described as ¿coded¿ in the intake) about 3 hours into the 3 hour 45 minute hd treatment utilizing the 2008t hd system.The patient did not complete treatment.The bmt did the functional checks and the ultrafiltration (uf) pump volume was low.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 patient¿s hd registered nurse, it was reported this patient experienced a cardiac arrest following a sudden drop in blood pressure that was caused by a myocardial infarction (mi) on (b)(6) 2022 during an hd treatment on the 2008t hd system in the dialysis clinic.Approximately three hours following the initiation of an hd treatment, the patient became unresponsive and pulseless.The patient was given cardiopulmonary resuscitation (cpr) by clinic staff when emergency services were activated.Paramedics arrived on the scene and resumed cpr while they transported the patient to the emergency department.The patient¿s mi leading to cardiac arrest was attributed to a significant cardiac disease history that was unrelated to renal replacement therapy.It was explained the patient experienced multiple mi¿s previously due to cardiac comorbidities, none of which were during an hd treatment.The patient had a return of systemic circulation, and he was admitted to the intensive care unit (icu) while mechanically ventilated and in critical condition.It was believed the patient continues hd therapy while hospitalized on a hospital provided hd device (unknown brand and model).The patient remains in critical condition while hospitalized in the icu with no discharge plans as of this reporting.It was confirmed the patient¿s mi leading to cardiac arrest was unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient will more than likely return to hd therapy on an in-center basis upon discharge to home.

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 hd machine and the patient¿s mi leading to cardiac arrest.The root cause of the patient¿s mi and cardiac arrest 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 risk of mortality, cardiac events, and fewer expected years of life when compared to the general population, particularly in the environment of cardiovascular disease.Additionally, hd patients are at the highest risk for out of hospital cardiac arrests with frequent occurrences in the dialysis clinic.Therefore, the 2008t hd system can be excluded as root cause of this patient¿s adverse event.Based on the required 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 event.

Event Description

A biomedical technician (bmt) reported to fresenius technical services this hemodialysis (hd) patient on in-center hd therapy experienced a cardiac arrest (described as ¿coded¿ in the intake) about 3 hours into the 3 hour 45 minute hd treatment utilizing the 2008t hd system.The patient did not complete treatment.The bmt did the functional checks and the ultrafiltration (uf) pump volume was low.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 patient¿s hd registered nurse, it was reported this patient experienced a cardiac arrest following a sudden drop in blood pressure that was caused by a myocardial infarction (mi) on (b)(6)/2022 during an hd treatment on the 2008t hd system in the dialysis clinic.Approximately three hours following the initiation of an hd treatment, the patient became unresponsive and pulseless.The patient was given cardiopulmonary resuscitation (cpr) by clinic staff when emergency services were activated.Paramedics arrived on the scene and resumed cpr while they transported the patient to the emergency department.The patient¿s mi leading to cardiac arrest was attributed to a significant cardiac disease history that was unrelated to renal replacement therapy.It was explained the patient experienced multiple mi¿s previously due to cardiac comorbidities, none of which were during an hd treatment.The patient had a return of systemic circulation, and he was admitted to the intensive care unit (icu) while mechanically ventilated and in critical condition.It was believed the patient continues hd therapy while hospitalized on a hospital provided hd device (unknown brand and model).The patient remains in critical condition while hospitalized in the icu with no discharge plans as of this reporting.It was confirmed the patient¿s mi leading to cardiac arrest was unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient will more than likely return to hd therapy on an in-center basis upon discharge to home.

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).Investigation determines that there was no causal relationship between the objective evidence and the alleged event; the alleged event is unconfirmed.A product history review was not completed during the investigation as the serial number was not provided.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 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: 15370920
• MDR Text Key: 299387445
• Report Number: 0002937457-2022-01476
• 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
• Report Date: 10/01/2022

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: 08/31/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2017
• 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 DIALYZER; FRESENIUS DIALYZER
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 69 KG