MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 191126

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Sepsis (2067); Loss of consciousness (2418)

Event Date 10/17/2019

Event Type  Death  

Manufacturer Narrative

Clinical review: a clinical investigation was performed. A temporal relationship exists between hd therapy utilizing the 2008t hemodialysis machine, and the adverse events of loss of consciousness, hypotension, cardiac arrest and sepsis which occurred on (b)(6) 2019. Although the patient was connected to the 2008t hemodialysis machine when the events occurred, there is no allegation or objective evidence indicating 2008t hemodialysis machine deficiency or malfunction caused the patient¿s loss of consciousness, hypotension, cardiac arrest or sepsis. Post event functional compliance testing verified the 2008t hemodialysis machine was functioning as per manufacturer¿s specification(s), and the clinic¿s cm also reported the events were unrelated to the utilization of any fresenius product or device. The source of the sepsis was an infected wound in the patient¿s gluteal fold. Infection is second to cardiovascular disease as the leading cause of death in patients with esrd. A temporal relationship does not exist between hd therapy utilizing the 2008t hemodialysis machine and the patient¿s second cardiac arrest and subsequent expiration, as the patient was not receiving hd therapy at the time of the events/death. The patient¿s primary cause of death was cardiac arrest, with a secondary cause of sepsis. Cardiovascular disease/event(s) account for most deaths in dialysis patients. However, based on the totality of the information available, as well as the lack of treatment record(s), discharge summary, autopsy and death certificate and esrd death notification, the 2008t hemodialysis machine cannot be excluded from having a possible contributory role in the events leading up to the patient¿s cardiac arrest and subsequent death. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

A fresenius res (regional equipment specialist) technician was called onsite by a user facility to repair a 2008t machine with a reported low tmp and failed optical detect test the res could not duplicate the reported issue. Machine functional tests were completed and passed onsite after repair. There was an adverse event reported during treatment. Upon follow up, the biomed stated that the patient coded during treatment. The outpatient clinical manager (cm) stated that the patient arrived for their scheduled treatment in stable condition. Approximately 2. 5 hours into a 4. 0-hour hd treatment (treatment record not provided), the patient was found unconscious during mid-treatment rounds (no reported alarms). The patient¿s blood was immediately returned, emergency medical services (ems) was contacted and cardiopulmonary resuscitation (cpr) efforts were initiated. During the code the patient was demonstrating agonal breathing, extreme hypotension (blood pressure not provided), and no pulse could be found. The user facility¿s automated external defibrillator (aed) was applied to the patient but advised ¿no shock¿ at the time. The patient was given approximately 1000 ml of normal saline, and 15 liters of oxygen via ambu bag. Ems arrived (timeline not provided), at which point the patient was transported to the hospital. Upon departure from the outpatient dialysis unit, the patient was noted to have a faint pulse. Once admitted, the cm reported the hospital discovered a large severely infected wound in the patient gluteal fold, which was treated with intravenous (iv) vancomycin and zosyn (dosage and frequency not provided) for reported septicemia. On (b)(6) 2019, the patient suffered a second cardiac arrest (not during hd therapy), and subsequently expired (specifics not provided). The cm stated the patient¿s primary cause of death was cardiac arrest, cause unknown, with a secondary cause of septicemia, other. The cm reported on (b)(6) 2019 and the 2008t hemodialysis machine failed pre-treatment machine testing, regarding the transmembrane pressure (tmp) and optical sensor (specifics not provided). The machine was sequestered following the events, and functional compliance testing/verification was ordered for the 2008t hemodialysis machine. The testing was performed on (b)(6) 2019 and found no nonconformances. The reported ¿optical detector failure¿ and ¿low tmp¿ could not be reproduced/replicated. The machine passed all testing, met manufacturer specifications and was returned to service. The cm stated the event was unrelated to the utilization of the 2008t hemodialysis machine and/or any fresenius device(s) or product(s). Subsequent attempts to obtain the treatment record, discharge summary, autopsy report, death certificate, and esrd death notification have thus far proven unsuccessful.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9283934
• MDR Text Key: 165211453
• Report Number: 2937457-2019-03340
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 11/06/2019 Patient Sequence Number: 1