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	03/19/2024
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
A biomedical technician (bmt) reported to technical support that a 2008t machine's blood pump rotor cut the dialysate blood pump tubing during a patient's hemodialysis (hd) treatment.The patient¿s estimated blood loss (ebl) is unknown.The complaint device is not available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.Should additional information become available, the file will be updated accordingly.
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a 2008t machine's blood pump rotor cut the dialysate blood pump tubing during a patient's hemodialysis (hd) treatment.The machine alarmed appropriately with an air detector alarm.The patient¿s ebl is unknown.The machine has 18,270 hours and blood pump rotor is not the original fresenius part on the machine.There was no patient injury, adverse event or medical intervention reported at intake.The patient was restarted on a new machine.The complaint device was reported to be available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.Should additional information become available, the file will be updated accordingly.
Additional Manufacturer Narrative
Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the gross visual examination of the sample, it was noted that the returned blood pump rotor has a missing sleeve (guide sheave) on one of the rear guide pin.The returned rotor was installed onto the blood pump module of a test machine for testing.A patient test was performed with fresenius¿s combiset bloodline and water in dialysis (blood pump rate set at 450 ml/min).The blood pump rotor functioned properly without any failures.The bloodline (tubing) was not damaged during the test.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 complaint was able to confirm the reported event.The cause was determined to be due to a mechanical problem and traced to component failure.
Event or Problem Description
A biomedical technician (bmt) reported to technical support that a 2008t machine's blood pump rotor cut the dialysate blood pump tubing during a patient's hemodialysis (hd) treatment.The patient¿s estimated blood loss (ebl) is unknown.The complaint device is not available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.Should additional information become available, the file will be updated accordingly.

• 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: 18992174
• Report Number: 0002937457-2024-00530
• Device Sequence Number: 12649993
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 04/18/2024

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: 03/19/2024
• Supplement Date Received by Manufacturer: 04/15/2024; 04/17/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 04/16/2024; 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2019
• 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 BLOODLINE; FRESENIUS BLOODLINE; FRESENIUS BLOODLINE
• Patient Sex: Unknown