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

Catalog Number	191128
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A fresenius field service technician (fst) was called onsite after the blood pump of a 2008t machine tore the tubing of the b.Braun bloodlines (not a fresenius product) during the patient's hemodialysis (hd) treatment.A user facility nurse confirmed the reported event during follow-up but declined to provide much of the additional information that was requested regarding the treatment.It was confirmed that the patient did not experience a serious injury or require medical intervention.The patient's estimated blood loss (ebl) was not provided.The fst replaced the blood pump module to resolve the reported issue.The machine passed functional testing and was returned to the customer.The sample is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Additional Manufacturer Narrative
Plant investigation: the blood pump module and blood pump rotor were returned to the manufacturer for physical evaluation.Visual inspections were completed on the returned samples.The blood pump module was returned with a scratch mark on the bottom ledge of the rotor housing and "unknown substance" on the tubing retaining clamp.There are no other discrepancies found with the blood pump module.The blood pump rotor has a loose and deformed guide sleeve one of the rear guide pins which can easily be removed from the pin.There are no other discrepancies found with the blood pump rotor.The samples were installed onto 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 bloodline tubing was not damaged and no fluid leaks occurred during the patient test.The reported blood pump failure alarm was not encountered during the patient test.The defective sleeve did not dislodge from the guide pin and there was no further damage to the rotor housing during the patient test.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.
Event or Problem Description
A fresenius field service technician (fst) was called onsite after the blood pump of a 2008t machine tore the tubing of the b.Braun bloodlines (not a fresenius product) during the patient's hemodialysis (hd) treatment.A user facility nurse confirmed the reported event during follow-up but declined to provide much of the additional information that was requested regarding the treatment.It was confirmed that the patient did not experience a serious injury or require medical intervention.The patient's estimated blood loss (ebl) was not provided.The fst replaced the blood pump module to resolve the reported issue.The machine passed functional testing and was returned to the customer.The sample is available to be returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HD SYS. W/O 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: 19772404
• Report Number: 0002937457-2024-01044
• Device Sequence Number: 12905183
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2024

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: 191128
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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
• Patient Sex: Unknown