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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that a 2008t machine did not detect a blood leak that occurred during a patient's hemodialysis (hd) treatment with a braun revaclear (non-fresenius) dialyzer.Additional information was provided during follow-up by the clinical coordinator.The blood leak was visually observed by the facility staff approximately 20 minutes prior to the completion of hemodialysis (hd) treatment.The blood leak was confirmed to be internal.The staff maintains that the machine never alarmed to indicate that a blood leak had occurred.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.Treatment ended approximately 20 minutes early.The patient's estimated blood loss (ebl) was approximately 180 ml.A fresenius field service technician (fst) was called onsite to evaluate the machine.A simulated treatment was performed and the machine provided a blood leak alarm without issue.The calibration of the blood leak detector was verified to be within range.No parts were replaced.The blood leak detector was determined to be operating as expected as the reported issue could not be duplicated.
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 user facility biomedical technician (biomed) reported to fresenius technical services that a 2008t machine did not detect a blood leak that occurred during a patient's hemodialysis (hd) treatment with a braun revaclear (non-fresenius) dialyzer.Additional information was provided during follow-up by the clinical coordinator.The blood leak was visually observed by the facility staff approximately 20 minutes prior to the completion of hemodialysis (hd) treatment.The blood leak was confirmed to be internal.The staff maintains that the machine never alarmed to indicate that a blood leak had occurred.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.Treatment ended approximately 20 minutes early.The patient's estimated blood loss (ebl) was approximately 180 ml.A fresenius field service technician (fst) was called onsite to evaluate the machine.A simulated treatment was performed and the the machine provided a blood leak alarm without issue.The calibration of the blood leak detector was verified to be within range.No parts were replaced.The blood leak detector was determined to be operating as expected as the reported issue could not be duplicated.
Additional Manufacturer Narrative
Correction: h3, h6 (types of investigation).
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical services that a 2008t machine did not detect a blood leak that occurred during a patient's hemodialysis (hd) treatment with a braun revaclear (non-fresenius) dialyzer.Additional information was provided during follow-up by the clinical coordinator.The blood leak was visually observed by the facility staff approximately 20 minutes prior to the completion of hemodialysis (hd) treatment.The blood leak was confirmed to be internal.The staff maintains that the machine never alarmed to indicate that a blood leak had occurred.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.Treatment ended approximately 20 minutes early.The patient's estimated blood loss (ebl) was approximately 180 ml.A fresenius field service technician (fst) was called onsite to evaluate the machine.A simulated treatment was performed and the the machine provided a blood leak alarm without issue.The calibration of the blood leak detector was verified to be within range.No parts were replaced.The blood leak detector was determined to be operating as expected as the reported issue could not be duplicated.
Additional 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).A simulated treatment was performed and the the machine provided a blood leak alarm without issue.The calibration of the blood leak detector was verified to be within range.No parts were replaced.The blood leak detector was determined to be operating as expected as the reported issue could not be duplicated.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 manufacturer did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.

• 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: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16648645
• Report Number: 0002937457-2023-00482
• Device Sequence Number: 14982629
• Product Code: KDI
• UDI-Device Identifier: 00840861100903
• UDI-Public: 00840861100903
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2023

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 05/09/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/08/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2015
• 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