MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190610
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A corporate manager of inventory reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow-up with the facility¿s charge nurse (cn).The blood leak was internal, and it occurred approximately two and a half hours into hd treatment.It was reported that a streak of blood was visually observed within the dialyzer, on the outside of the fibers.The machine, a fresenius 2008k2 machine, did not alarm with a blood leak alert.A blood leak test strip was used to test the dialysate for blood, and it tested positive.No physical damage was noted on the dialyzer.Fresenius bloodlines were also being utilized during the treatment.After the blood streak was identified, the treatment was paused.The patient¿s blood was not returned.Estimated blood loss (ebl) was 300 ml.The cn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.Following the event, the machine was removed from service for evaluation.The facility¿s biomedical technician (biomed) was unable to duplicate the reported failure.The biomed recalibrated the blood leak detector, ran the machine through testing, and then determined it was ready to be put back in service.
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 corporate manager of inventory reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow-up with the facility¿s charge nurse (cn).The blood leak was internal, and it occurred approximately two and a half hours into hd treatment.It was reported that a streak of blood was visually observed within the dialyzer, on the outside of the fibers.The machine, a fresenius 2008k2 machine, did not alarm with a blood leak alert.A blood leak test strip was used to test the dialysate for blood, and it tested positive.No physical damage was noted on the dialyzer.Fresenius bloodlines were also being utilized during the treatment.After the blood streak was identified, the treatment was paused.The patient¿s blood was not returned.Estimated blood loss (ebl) was 300 ml.The cn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.Following the event, the machine was removed from service for evaluation.The facility¿s biomedical technician (biomed) was unable to duplicate the reported failure.The biomed recalibrated the blood leak detector, ran the machine through testing, and then determined it was ready to be put back in service.
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).The complaint investigation did not find objective evidence indicating a product problem, and thus the complaint was unconfirmed.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.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 17502877
• Report Number: 0002937457-2023-01177
• Device Sequence Number: 12461646
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K994267
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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 Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2013
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 66 KG