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

Catalog Number	190895
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/04/2024
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
The facility administrator (fa) from a hemodialyis (hd) user facility reported that a 2008t hd machine had a blood pump rotor failure that occurred during a patient¿s treatment.Within the first twenty minutes of the treatment, the staff observed a small blood leak coming from the blood pump and leaking down the front of the machine.It was unknown if the machine alarmed.The treatment was terminated, and the patient's blood was returned.Following the event, the fa said the staff was reeducated and instructed not to return the blood if this were to reoccur.The doctor was notified of the event.As a precaution, the patient was given prophylactic antibiotics and had two blood cultures taken.However, the patient was confirmed to be asymptomatic.The patient did not experience any adverse effects or require medical intervention.The patient was re-setup with new supplies on a different machine where they were able to complete their treatment.The machine that the leak occurred on was removed from service.Upon removal of the combi set bloodlines, a cut was identified on the tubing segment that sits in the blood pump rotor.The fa confirmed that the bloodlines were inspected prior to use, and no damage was found at that time.The fa also confirmed there were no leaks during the priming phase.The patient's estimated blood loss (ebl) due to the leak was less than 15 ml.After speaking with the biomed, it was reported that the pins on the blood pump rotor were bent, and the face plate was cracked.To resolve the reported issue, the blood pump rotor was replaced.The machine was put back in service following the repair.The biomed stated the damaged blood pump rotor was available to be returned for evaluation.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However, the complaint investigation found objective evidence indicating a product problem, and thus the complaint was confirmed.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.Based on the available information, the reported event has been confirmed.
Event or Problem Description
The facility administrator (fa) from a hemodialyis (hd) user facility reported that a 2008t hd machine had a blood pump rotor failure that occurred during a patient¿s treatment.Within the first twenty minutes of the treatment, the staff observed a small blood leak coming from the blood pump and leaking down the front of the machine.It was unknown if the machine alarmed.The treatment was terminated, and the patient's blood was returned.Following the event, the fa said the staff was reeducated and instructed not to return the blood if this were to reoccur.The doctor was notified of the event.As a precaution, the patient was given prophylactic antibiotics and had two blood cultures taken.However, the patient was confirmed to be asymptomatic.The patient did not experience any adverse effects or require medical intervention.The patient was re-setup with new supplies on a different machine where they were able to complete their treatment.The machine that the leak occurred on was removed from service.Upon removal of the combi set bloodlines, a cut was identified on the tubing segment that sits in the blood pump rotor.The fa confirmed that the bloodlines were inspected prior to use, and no damage was found at that time.The fa also confirmed there were no leaks during the priming phase.The patient's estimated blood loss (ebl) due to the leak was less than 15 ml.After speaking with the biomed, it was reported that the pins on the blood pump rotor were bent, and the face plate was cracked.To resolve the reported issue, the blood pump rotor was replaced.The machine was put back in service following the repair.The biomed stated the damaged blood pump rotor was available to be returned for evaluation.

• 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: 20306933
• Report Number: 0002937457-2024-01421
• Device Sequence Number: 7744740
• Product Code: KDI
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 190895
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2017
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 65 KG