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

Model Number 191126

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

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 09/16/2022

Event Type  Injury  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hd machine and the patient¿s hypotensive episode leading to a loss of consciousness and agonal breathing.The source of the patient¿s adverse event can be attributed to the patient¿s prior non-compliance to hd therapy and cardiac comorbidities as reported by a medical professional.It is well established hypotension is the most common complication of hd therapy.Additionally, dialysis patients with cardiovascular disease have an increased risk of intradialytic hypotensive episodes.Therefore, the 2008t hd system can be excluded as root cause of this patient¿s adverse event.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-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 determined that there was no causal relationship between the objective evidence and the alleged event; the alleged event is unconfirmed.A definitive conclusion regarding the complaint incident cannot be reached.

Event Description

The biomedical technician (biomed) reported to fresenius technical services that a ¿patient incident¿ occurred with a hemodialysis (hd) patient during a treatment on a fresenius 2008t machine.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 became hypotensive and unconscious with agonal respirations during an hd treatment.After approximately two and a half hours into an hd treatment, the patient insisted on standing up for comfort reasons.The patient was attempting to stand, against the direction of clinic staff, and became hypotensive and unconscious with agonal respirations.Clinic staff activated emergency services while providing the patient 100% oxygen via a bag valve mask.No blood loss occurred, as it was returned to the patient.Emergency services arrived on the scene and the patient was transported to the hospital where he was admitted to the intensive care unit on the same day.The patient was intubated and placed on mechanical ventilation during this admission.The cause of the patient¿s hypotensive event leading to a loss of consciousness and agonal breathing was attributed to a recent history of non-compliance with hd orders and cardiac comorbidities unrelated to dialysis or the use of any fresenius product(s) or device(s).It was explained the patient has regularly missed hd treatments and the treatment on the day of this event was a make-up treatment from a previously missed appointment.The patient was extubated and moved to a general medical floor on hospital day two.The patient was able to undergo hd therapy on a hospital provided hd device (unknown brand and model) for the duration of the admission.The patient had an otherwise uneventful hospital course and was discharged to home.It was confirmed the patient¿s hypotensive episode, loss of consciousness, agonal breathing and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s) or device(s).The patient continues hd therapy on an in-center basis post-discharge.

• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15586632
• MDR Text Key: 301557368
• Report Number: 0002937457-2022-01703
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 58 KG