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

Model Number	191128
Medical Device Problem Codes	Mechanical Problem (1384); Reflux within Device (1522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A hemodialysis (hd) user facility reported that a fresenius 2008t hd machine experienced a saline bag filling error and had high transmembrane pressure (tmp).A fresenius field service technician (fst) was dispatched to the facility to evaluate the machine.Additional details were revealed when the fst arrived onsite.The clinic manager (cm) at the facility explained to the fst that the machine was set up incorrectly and the saline backfill was caused by use error.The cm told the fst that one of the lines was left unclamped.Per the cm, they changed the setup and it resolved the issue.However, the tmp was still high.It was confirmed that this occurred during priming; there was no patient involvement.During testing, the fst could not duplicate the saline bag filling error or the high transmembrane pressure (tmp) problem.As a precaution, the fst calibrated the dialysate pressure.They also calibrated the bicarb pump and the concentrate pump.The fst confirmed that the cbe upgrades had been completed on the machine, and that there were no reports of the machine giving any filling programs.The fst said the machine was returned to service upon their departure, and they did not have any knowledge of there being further issues.The saline bag filling error was caused by use error, and this was acknowledged by the reporting facility.
Event or Problem Description
A hemodialysis (hd) user facility reported that a fresenius 2008t hd machine experienced a saline bag filling error and had high transmembrane pressure (tmp).A fresenius field service technician (fst) was dispatched to the facility to evaluate the machine.Additional details were revealed when the fst arrived onsite.The clinic manager (cm) at the facility explained to the fst that the machine was set up incorrectly and the saline backfill was caused by use error.The cm told the fst that one of the lines was left unclamped.Per the cm, they changed the setup and it resolved the issue.However, the tmp was still high.It was confirmed that this occurred during priming; there was no patient involvement.During testing, the fst could not duplicate the saline bag filling error or the high transmembrane pressure (tmp) problem.As a precaution, the fst calibrated the dialysate pressure.They also calibrated the bicarb pump and the concentrate pump.The fst confirmed that the cbe upgrades had been completed on the machine, and that there were no reports of the machine giving any filling programs.The fst said the machine was returned to service upon their departure, and they did not have any knowledge of there being further issues.The saline bag filling error was caused by use error, and this was acknowledged by the reporting facility.
Additional Manufacturer Narrative
Additional information: h3 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 saline bag filling error was determined to be caused by use error.As a precaution, the fst calibrated the dialysate pressure, the bicarb pump, and the concentrate pump.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 fst could not duplicate the saline bag filling error or the high transmembrane pressure (tmp) problem.It was confirmed that the reported failure was caused by use error.Based on the available information, the reported failure mode could not be confirmed.

• Brand Name: 2008T HD SYS. W/O 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
• 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: 13873989
• Report Number: 2937457-2022-00461
• Device Sequence Number: 20006780
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 191128
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2020
• 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 Sex: Unknown