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	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (bmt) reported a 2008k2 uf check valve 63 leaked during a patient's hemodialysis (hd) treatment and the machine was pulled.The bmt was unsure of the patient finished treatment.Per bmt there was no patient injury.The bmt stated one of the plastic tabs holding the two halves of the check valve failed and the check valve broke apart.The check valve was replaced to resolve the issue.Upon follow-up, the bmt stated the uf check valve was noticed to have been split apart during the patient's treatment, causing a blood leak.The machine reportedly alarmed appropriately during treatment as a result of the leak.The estimated blood loss (ebl) was unknown.It was unknown if any damage was noted to the uf check valve prior to treatment or what may have attributed to the check valve breaking apart, but stated the machine had passed pre-checks prior to the patient's treatment.The bmt stated it was unknown if the patient was able to complete their treatment following the reported event, and confirmed there was no known patient injury as a result of the reported issue, with no harm or adverse events reported.The bmt stated the machine was replaced with a new check valve, was disinfected and returned to service.A requested sample was no longer available to be returned for evaluation.
Additional Manufacturer Narrative
Plant investigation: 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.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 able to be confirmed due to broke uf check valve.
Event or Problem Description
A user facility biomedical technician (bmt) reported a 2008k2 uf check valve 63 leaked during a patient's hemodialysis (hd) treatment and the machine was pulled.The bmt was unsure of the patient finished treatment.Per bmt there was no patient injury.The bmt stated one of the plastic tabs holding the two halves of the check valve failed and the check valve broke apart.The check valve was replaced to resolve the issue.Upon follow-up, the bmt stated the uf check valve was noticed to have been split apart during the patient's treatment, causing a blood leak.The machine reportedly alarmed appropriately during treatment as a result of the leak.The estimated blood loss (ebl) was unknown.It was unknown if any damage was noted to the uf check valve prior to treatment or what may have attributed to the check valve breaking apart, but stated the machine had passed pre-checks prior to the patient's treatment.The bmt stated it was unknown if the patient was able to complete their treatment following the reported event, and confirmed there was no known patient injury as a result of the reported issue, with no harm or adverse events reported.The bmt stated the machine was replaced with a new check valve, was disinfected and returned to service.A requested sample was no longer available to be returned for evaluation.

• 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: 18989175
• Report Number: 0002937457-2024-00522
• Device Sequence Number: 2858367
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: Other
• Device Catalogue Number: 190610
• 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: 03/21/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2009
• 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 DIALYZER; FRESENIUS DIALYZER
• Patient Sex: Unknown