MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	191124
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak was coming from the combi set bloodline, but it was reportedly caused by the blood pump rotor.A tear was identified in the line, which was reportedly damaged by the blood pump rotor.The blood leak occurred approximately 3 hours into treatment.The machine alarmed appropriately with an air detector alarm.The patient¿s blood was returned, and a minimal amount of blood was lost, but could not be quantified.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported events.To resolve the reported issue, the biomed replaced the blood pump rotor.The blood pump rotor was reported to be available for evaluation.
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¿s biomedical technician (bmt) reported that a blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak was coming from the combi set bloodline, but it was reportedly caused by the blood pump rotor.A tear was identified in the line, which was reportedly damaged by the blood pump rotor.The blood leak occurred approximately 3 hours into treatment.The machine alarmed appropriately with an air detector alarm.The patient¿s blood was returned, and a minimal amount of blood was lost, but could not be quantified.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported events.To resolve the reported issue, the biomed replaced the blood pump rotor.The blood pump rotor was reported to be available for evaluation.
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An exterior visual inspection of the returned blood pump rotor revealed a damaged sleeve (guide sheave) on one of the rear guide pins that can easily be removed from the pin.The pin had signs of debris.The returned sample was subjected to a functional test wherin the returned rotor was installed onto the blood pump module of a test machine.A patient test was performed with fresenius¿s combiset bloodline and water in dialysis (blood pump rate set at 450 ml/min) for 2 hours.The rotor did not damage the bloodline and there were no fluid leaks nor alarms during testing.The damaged rear sleeve stayed intact on the guide pin and did not dislodge during the test.Upon completion of the evaluation, the reported issue was confirmed and the cause was determined to be component failure of the blood tubing roller guide.
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak was coming from the combi set bloodline, but it was reportedly caused by the blood pump rotor.A tear was identified in the line, which was reportedly damaged by the blood pump rotor.The blood leak occurred approximately 3 hours into treatment.The machine alarmed appropriately with an air detector alarm.The patient¿s blood was returned, and a minimal amount of blood was lost, but could not be quantified.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported events.To resolve the reported issue, the biomed replaced the blood pump rotor.The blood pump rotor was reported to be available for evaluation.

• Brand Name: 2008T HD SYS. CDX BLUE STAR
• 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: 18809283
• Report Number: 0002937457-2024-00351
• Device Sequence Number: 17934328
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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,Followup
• Report Date (Section B): 03/19/2024

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: Health Professional
• Device Catalogue Number: 191124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 03/15/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/19/2024; 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2020
• 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 COMBISET BLOODLINE; FRESENIUS COMBISET BLOODLINE; FRESENIUS COMBISET BLOODLINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Sex: Unknown