MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190766

Device Problem No Audible Alarm (1019)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/24/2023

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A clinic manager reported that during a hemodialysis (hd) treatment there was a blood leak.In a follow up a registered nurse (rn) clarified that the blood leak occurred fifteen minutes after starting the hd treatment.The blood leak was described as being an internal blood leak.The leak was visually seen in the outflow line of the dialyzer.The machine, a fresenius 2008t machine did not alarm with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 300 ml.There was no patient injury, adverse events or medical intervention required as a result of this event.The treatment was completed the same day with new supplies on a different machine.

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 clinic manager reported that during a hemodialysis (hd) treatment there was a blood leak.In a follow up a registered nurse (rn) clarified that the blood leak occurred fifteen minutes after starting the hd treatment.The blood leak was described as being an internal blood leak.The leak was visually seen in the outflow line of the dialyzer.The machine, a fresenius 2008t machine did not alarm with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 300 ml.There was no patient injury, adverse events or medical intervention required as a result of this event.The treatment was completed the same day with new supplies on a different machine.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 17330335
• MDR Text Key: 319272355
• Report Number: 0002937457-2023-01019
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 BLOODLINES; OPTIFLUX 160NRE DIALYZER; OPTIFLUX 160NRE DIALYZER
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 60 KG