MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	190895
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2022
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 user facility biomedical technician (biomed) reported to fresenius that a patient experienced blood loss after a 2008t machine powered down twice during their hemodialysis (hd) treatment.The machine could be restarted after the first occurrence but not after the second occurrence which prevented the patient's blood from being returned.Additional information regarding the treatment was requested however a response was not received.It was stated in the initial report that the patient did not experience an adverse event or serious injury as a result of the reported issue.The patient's estimated blood loss (ebl) was not provided.Treatment was not restarted after the reported issue had occurred.The biomed stated during followup that the front panel keypad and power logic board were replaced to resolve the reported issue.The machine has been returned to service.The power logic board is available to be returned to the manufacturer for a physical evaluation.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius that a patient experienced blood loss after a 2008t machine powered down twice during their hemodialysis (hd) treatment.The machine could be restarted after the first occurrence but not after the second occurrence which prevented the patient's blood from being returned.Additional information regarding the treatment was requested however a response was not received.It was stated in the initial report that the patient did not experience an adverse event or serious injury as a result of the reported issue.The patient's estimated blood loss (ebl) was not provided.Treatment was not restarted after the reported issue had occurred.The biomed stated during followup that the front panel keypad and power logic board were replaced to resolve the reported issue.The machine has been returned to service.The power logic board is available to be returned to the manufacturer for a physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 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 manufacturer during its investigation was able to determine a causal relationship between the objective evidence and the alleged event; the alleged event is confirmed.

• Brand Name: 2008T GEN 2 BIBAG 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: 15029807
• Report Number: 0002937457-2022-01185
• Device Sequence Number: 14591858
• Product Code: KDI
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: 190895
• Device Catalogue Number: 190895
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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