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

Model Number 191124

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

Patient Problem Cardiac Arrest (1762)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between hemodialysis treatment utilizing the 2008 hemodialysis cdx blue star machine and the patient event of coding with subsequent death.However, there is no documentation within the complaint to show a causal relationship between the adverse event and use of the machine.The patient was informed that a heart transplant would be required and that their ejection fraction was 5-10% a few days prior to the adverse event.The risk for sudden cardiac arrest is significantly increased with an ef lower than 35%.Based on the available information and no allegation or evidence of a machine malfunction, the 2008 hemodialysis cdx blue star machine can be excluded as the cause of the patient¿s coding event and subsequent death.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical support that a patient coded while on a 2008 hemodialysis (hd) machine and passed away later that day.The biomed stated that the adverse event was not thought to be machine related.The biomed wanted to know if it was mandatory for a fresenius technician to evaluate the machine.Additional information was obtained through follow-up with the hd clinic director.The patient was in a regularly scheduled hd treatment when they coded.The treatment was initiated at 6:30am and the adverse event occurred at 9:30am.Later that day (exact time not provided), the patient expired.The patient had been discharged from the clinic three days prior to the dialysis treatment where they were informed their ejection fraction (ef) was 5-10% and that they would require a heart transplant.It was reported that the coding event and death were not related to the dialysis treatment or use of the 2008 hd machine.Cultures were sent out on the dialysate which all resulted normal.The lines were retained until the machine evaluations were completed.All evaluations were completed with no findings.The event was attributed to the patient¿s cardiac condition.No additional information was provided.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical support that a patient coded while on a 2008t hemodialysis (hd) machine and passed away later that day.The biomed stated that the adverse event was not thought to be machine related.The biomed wanted to know if it was mandatory for a fresenius technician to evaluate the machine.Additional information was obtained through follow-up with the hd clinic director.The patient was in a regularly scheduled hd treatment when they coded.The treatment was initiated at 6:30am and the adverse event occurred at 9:30am.Later that day (exact time not provided), the patient expired.The patient had been discharged from the clinic three days prior to the dialysis treatment where they were informed their ejection fraction (ef) was 5-10% and that they would require a heart transplant.It was reported that the coding event and death were not related to the dialysis treatment or use of the 2008t hd machine.Cultures were sent out on the dialysate which all resulted normal.The lines were retained until the machine evaluations were completed.All evaluations were completed with no findings.The event was attributed to the patient¿s cardiac condition.No additional information was provided.

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-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 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 HD SYS. CDX 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13143963
• MDR Text Key: 284176640
• Report Number: 2937457-2022-00006
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 191124
• Device Catalogue Number: 191124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• 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): Life Threatening; Death
• Patient Age: 63 YR
• Patient Sex: Female