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

Catalog Number 191130

Device Problem Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/21/2023

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 hemodialysis (hd) user facility reported that a fresenius 2008t hd machine failed to alarm with a high venous pressure alarm or a high transmembrane pressure (tmp) alarm while a patient was clotting during treatment.Due to the alarm failure, the staff did not realize the patient was clotting and the patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) due to the event was 250 ml.Additional details were provided upon follow-up with the user facility¿s biomedical technician (biomed) and facility administrator (fa).It was confirmed that the patient is very prone to clotting - this was not the concerning part.What was concerning was that the machine failed to notify the staff when it began to happen.It was explained that the machines normally alarm with some sort of pressure alarm when a patient is clotting, and that didn¿t happen in this scenario.It was reported that an air detector alarm occurred, but this didn¿t happen until the system had completely clotted.It was confirmed the patient did not experience any adverse effects or require medical intervention.The machine was removed from service for testing and evaluated by the biomed.The biomed stated there were no problems found during the machine inspection, and there were no issues with the heparin pump.The patient was utilizing a fresenius optiflux dialyzer with fresenius bloodlines.However, the fa stated there were no issues with the disposable supplies.It was reiterated that the blood loss occurred because the machine failed to alarm appropriately to notify the operator of the clotting.The machine was confirmed to be back in service and fully functional.

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).However, the complaint investigation was able to find objective evidence indicating a product problem, and thus the complaint was 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.Based on the available information, the complaint was confirmed.

Event Description

A hemodialysis (hd) user facility reported that a fresenius 2008t hd machine failed to alarm with a high venous pressure alarm or a high transmembrane pressure (tmp) alarm while a patient was clotting during treatment.Due to the alarm failure, the staff did not realize the patient was clotting and the patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) due to the event was 250 ml.Additional details were provided upon follow-up with the user facility¿s biomedical technician (biomed) and facility administrator (fa).It was confirmed that the patient is very prone to clotting - this was not the concerning part.What was concerning was that the machine failed to notify the staff when it began to happen.It was explained that the machines normally alarm with some sort of pressure alarm when a patient is clotting, and that didn¿t happen in this scenario.It was reported that an air detector alarm occurred, but this didn¿t happen until the system had completely clotted.It was confirmed the patient did not experience any adverse effects or require medical intervention.The machine was removed from service for testing and evaluated by the biomed.The biomed stated there were no problems found during the machine inspection, and there were no issues with the heparin pump.The patient was utilizing a fresenius optiflux dialyzer with fresenius bloodlines.However, the fa stated there were no issues with the disposable supplies.It was reiterated that the blood loss occurred because the machine failed to alarm appropriately to notify the operator of the clotting.The machine was confirmed to be back in service and fully functional.

• Brand Name: 2008T HD SYS. W/O 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: 18313869
• MDR Text Key: 330936193
• Report Number: 0002937457-2023-01869
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

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: 191130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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 OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.