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

Catalog Number 190713

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/19/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A facility administrator (fa) reported to technical support that a 2008t blood pump rotor cut the tubing blood lines.Upon follow-up, the fa stated during a patient's hemodialysis (hd) treatment the blood pump rotor slit the blood pump tubing, causing a blood leak to occur.The fa stated treatment was immediately stopped when the blood leak was observed.The fa stated the blood pump rotor was removed from service.Per fa it was unknown if the rotor was original to the machine.The fa stated that a fresenius dialyzer and bloodlines were used for treatment and confirmed that there were no defects or damage seen on the machine or bloodline prior to the event.The fa stated the patient was three hours and two minutes into treatment remaining when the event occurred and stated treatment was immediately halted and the patient¿s blood was not returned.The fa stated the estimated blood loss was 300cc.Immediately following the event, the patient was switched over to a different machine and resumed and completed treatment without further issue.The fa confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The fa stated the component was available to be returned for manufacturer evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 able to be confirmed.

Event Description

A facility administrator (fa) reported to technical support that a 2008t blood pump rotor cut the tubing blood lines.Upon follow-up, the fa stated during a patient's hemodialysis (hd) treatment the blood pump rotor slit the blood pump tubing, causing a blood leak to occur.The fa stated treatment was immediately stopped when the blood leak was observed.The fa stated the blood pump rotor was removed from service.Per fa it was unknown if the rotor was original to the machine.The fa stated that a fresenius dialyzer and bloodlines were used for treatment and confirmed that there were no defects or damage seen on the machine or bloodline prior to the event.The fa stated the patient was three hours and two minutes into treatment remaining when the event occurred and stated treatment was immediately halted and the patient¿s blood was not returned.The fa stated the estimated blood loss was 300cc.Immediately following the event, the patient was switched over to a different machine and resumed and completed treatment without further issue.The fa confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The fa stated the component was available to be returned for manufacturer evaluation.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 19214399
• MDR Text Key: 341437223
• Report Number: 0002937457-2024-00702
• Device Sequence Number: 1
• Product Code: KDI
• 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,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 04/26/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2017
• 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; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 67 KG