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	04/30/2021
Type of Reportable Event	Malfunction
Additional 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.
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.During the treatment the patient's blood pressure dropped.A saline bolus of 55 cc was administered to the patient per standing order (ordered by the physician).The patient has been diagnosed with spina bifida.The clinical manager explained that the patient's drop in blood pressure was related to this diagnosis and not a complication of treatment.There was no patient injury, adverse events, or medical intervention required as a result of the reported event.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: 11879173
• Report Number: 2937457-2021-01115
• Device Sequence Number: 1099335
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

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: 05/11/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 12 MO
• Patient Weight: 9