MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	190858
Medical Device Problem Code	Inadequate Ultra Filtration (1656)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility hemodialysis (hd) nurse reported that the ultrafiltration (uf) started but the clocks are not counting down.The nurse reported that the machine is setup for a pediatric patient with the goals and times set.The patient was connected to the machine and the "treatment start" button was pressed which began treatment and caused the uf button to go green.However both treatment time and uf time clocks did not start counting down.Technical support had the nurse stop treatment using the "treatment pause" button.Treatment was restarted but the uf counted up while both treatment time and uf clocks remained at time set.The nurse stated there was no way to tell when treatment started but the ultrafiltration (uf) was still progressing.The nurse confirmed that there were no adjustments made to the patient's uf goal, rate, or time.Technical support recommended removing the patient from the machine and removing the machine from service until a full evaluation is performed to determine the cause of the clock errors.The uf was not turned off at all during treatment.It is unknown if the up/down arrow keys were used to program the initial setting.The patient was able to successfully complete treatment on a blue star machine and the correct amount of fluid was removed from the patient at the end of treatment.The patient¿s pre and post weights were as expected and the same scale was used for both readings.The patient had a bottle of 80 ml during treatment.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 nurse, the machine has not been returned to service due to waiting for the field service technician (fst) to replace an internal board.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
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 hemodialysis (hd) nurse reported that the ultrafiltration (uf) started but the clocks are not counting down.The nurse reported that the machine is setup for a pediatric patient with the goals and times set.The patient was connected to the machine and the "treatment start" button was pressed which began treatment and caused the uf button to go green.However both treatment time and uf time clocks did not start counting down.Technical support had the nurse stop treatment using the "treatment pause" button.Treatment was restarted but the uf counted up while both treatment time and uf clocks remained at time set.The nurse stated there was no way to tell when treatment started but the ultrafiltration (uf) was still progressing.The nurse confirmed that there were no adjustments made to the patient's uf goal, rate, or time.Technical support recommended removing the patient from the machine and removing the machine from service until a full evaluation is performed to determine the cause of the clock errors.The uf was not turned off at all during treatment.It is unknown if the up/down arrow keys were used to program the initial setting.The patient was able to successfully complete treatment on a blue star machine and the correct amount of fluid was removed from the patient at the end of treatment.The patient¿s pre and post weights were as expected and the same scale was used for both readings.The patient had a bottle of 80 ml during treatment.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 nurse, the machine has not been returned to service due to waiting for the field service technician (fst) to replace an internal board.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• 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
• 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: 12752893
• Report Number: 2937457-2021-02231
• Device Sequence Number: 4560095
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113427
• 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 Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: 190858
• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 11/04/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 9 MO
• Patient Sex: Male
• Patient Weight: 6 KG