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

Model Number	191124
Medical Device Problem Code	Inadequate Ultra Filtration (1656)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).Additionally, a serial number for the machine could not be provided which prevented the manufacturer from performing a product history review.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.
Event or Problem Description
A user facility manager reported that the ultrafiltration (uf) goal and treatment time changed on a fresenius 2008t hemodialysis (hd) machine after the initiation of the patient's treatment.The machine was programed to a uf goal of 800 ml and treatment time of 3 hours, however, after initiation it was noted that the machine defaulted to a uf rate of 70 ml/hour.The clinical manager stated that the machine could not manually be adjusted to what was programmed by the staff.The uf was not turned off at all during treatment.At that point, treatment was terminated.There was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient did not have any complaints or symptoms related to the reported event and no additional treatments were required.Per the clinical manager, the reported event could not be duplicated during testing and the machine was returned to service and no parts were replaced or machine repairs made.

• Brand Name: 2008T HD SYS. CDX BLUE STAR
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 11839001
• Report Number: 2937457-2021-01062
• Device Sequence Number: 14588907
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 191124
• Device Catalogue Number: 191124
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS DIALYZER
• Patient Age: 11 MO
• Patient Weight: 9