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

Catalog Number 191126

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/05/2023

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow up with the facility¿s clinical manager (cm).The cm described the details of the scenario as "unique".When the hd machine (a fresenius 2008t) was put into sequential mode at the beginning of treatment, it alarmed with a blood leak alarm.The staff tested the drain with a blood test strip, and it tested positive.The staff then turned sequential mode off and tested the drain again, and it tested negative.The alarm was cleared, and the patient¿s treatment was continued.After about two hours of treatment, the cm learned what had happened and advised the staff to use another blood test strip.This time the test strip was ¿faintly positive¿, and the cm told the staff that the treatment had to be stopped.The cm confirmed there was only one blood leak alarm, which occurred at the beginning of the treatment.The machine did not alarm again after that.Per the cm, the blood leak was not visually observed; it was not obvious that an internal blood leak had occurred.There were no defects noted on the dialyzer.The patient¿s blood was not returned; estimated blood loss (ebl) was 250 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The machine involved was removed from service for evaluation.The cm contacted the area technical operations manager (atom) to ask that it be inspected.It was confirmed that the machine was returned to service afterwards.In additional follow up with the atom, it was reported that ¿a pressure and alarm test passed on the machine.The blood leaks was 4.99 volts (range 4.5-5.2), and the dimness was 5.04 volts (range 4.0-6.0).The machine was bleached and leaks and dims calibrated even though they were still within the allowable range.No parts replaced.¿ [sic] further clarification could not be obtained from the atom despite multiple follow up attempts.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Type of Device: 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: 18422436
• MDR Text Key: 331694478
• Report Number: 0002937457-2023-01967
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FRESENIUS BLOODLINES; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 68 KG