MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number 190895

Device Problem Fluid/Blood Leak (1250)

Patient Problem Death (1802)

Event Date 08/31/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician reported a patient who expired during treatment on a fresenius 2008t hemodialysis (hd) machine.After the patient¿s treatment started, the machine gave arterial and venous alarms, and it was noted that blood was clotting in the bloodlines.The blood lines were replaced twice with a blood loss of 300ml.During the swapping of the second set of blood lines it was noted that there was no flow in the bloodlines, and the patient was moved to a new fresenius 2008t machine.Within 5 minutes of being moved to the new machine, the patient coded and subsequently expired.The first 2008t machine was inspected, was not found to have any issues, and returned to service.The second machine was found to have backed out rotor pins on the blood pump, which caused the rotor to be misaligned with the blood pump housing.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: there is a temporal relationship between the patient event of blood clotting, coding, and subsequent death and their hemodialysis (hd) treatment on the fresenius 2008t machine.However, there is no documentation to show that the 2008t machine caused the clotting issue and death of the patient.The machine alarmed to alert of an issue with the arterial and venous lines.Priming the lines two more times did not resolve the issue.A clot was suspected but not visible to the surgeon on site.It is unknown if there was a clot causing the issue.There is no treatment record to show anticoagulation use.The patient¿s therapy was restarted on a new machine but she coded within five minutes of restarting treatment.The patient expired when a family member stated the patient was a do not resuscitate.It is unknown if the patient had pre-existing co-morbidities that contributed to the event.The initial machine was evaluated without any findings, however, the second machine was found to have the blood pump rotor pins backing out so it was misaligned within the housing.Based on available information, it cannot be concluded if the hemodialysis machine could have caused or contributed to the event.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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.

Manufacturer Narrative

Event description updated to capture correct information regarding event.

Event Description

A user facility biomedical technician reported a patient who expired during treatment on a fresenius 2008t hemodialysis (hd) machine.After the patient¿s treatment started, the machine gave arterial and venous alarms, and it was noted that blood was clotting in the bloodlines.The blood lines were replaced twice with a blood loss of 300ml.During the swapping of the second set of blood lines it was noted that there was no flow in the bloodlines, and the patient was moved to a new fresenius 2008t machine.Within 5 minutes of being moved to the new machine, the patient coded and subsequently expired.The patient had a standing do not resuscitate order, and no attempt was made to resuscitate the patient.The first 2008t machine was inspected and was found to have backed out rotor pins on the blood pump, which caused the rotor to be misaligned with the blood pump housing.The second machine was inspected, was not found to have any issues, and returned to service.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT CDX
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7869163
• MDR Text Key: 119973023
• Report Number: 2937457-2018-02692
• Device Sequence Number: 0
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 87 YR