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 Problem Cardiac Arrest (1762)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).The fst found the machine to be operating within specifications.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.The machine underwent and passed functional checks, and was found to be operating within specifications.Clinical investigation: there is a temporal relationship between hd therapy utilizing the 2008t machine and the patient event of coding.However, there is no documentation in the complaint file to show a causal relationship between use of the machine and the patient adverse event.Additionally, there was no allegation of a machine malfunction or deficiency and the machine evaluation found no issues.The machine evaluation was completed at the clinic's request due to the patient event.Although the cause of the patient coding during treatment is unconfirmed, end stage renal disease (esrd) patients have a high prevalence of cardiovascular disease.Based on the limited information and no allegation of a malfunction or deficiency, the fresenius 2008t machine can be excluded as the cause of the patient¿s adverse event.

Event Description

A user facility biomedical technician (bmt) reported that a hemodialysis (hd) patient coded during their treatment while connected to a fresenius 2008t machine.Post-event, the bmt requested an onsite evaluation of the machine.A fresenius field service technician (fst) was dispatched to the user facility.The fst confirmed that a patient coded during their treatment on the machine.The patient was resuscitated and discharged to the hospital from the clinic.The fst performed an evaluation and found the machine to be operating within specifications.The machine underwent and passed functional checks.Multiple attempts to obtain additional information were unsuccessful.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9913373
• MDR Text Key: 186519658
• Report Number: 2937457-2020-00575
• 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: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/01/2020

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: Health Professional
• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2011
• 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