MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Loss of consciousness (2418)

Event Date 02/05/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: a temporal relationship exists between hd therapy with the 2008k2 hemodialysis machine and the patient¿s loss of consciousness, characterized by hypovolemia and hypotension.However, the 2008k2 hemodialysis machine can be disassociated from these event(s), as there is no evidence a machine deficiency or malfunction was associated with these event(s).The patient reportedly had an episode of intradialytic hypotension during hd therapy which led to a loss of consciousness, and hd therapy was discontinued.Per the hdrn, the event(s) were unrelated to the functionality of the 2008k2 hemodialysis machine.The intravascular volume changes which occurred during hd therapy, in addition to the patient¿s cardiac status and hemodynamic instability were all contributing factors.Additionally, the 2008k2 hemodialysis machine passed all functional compliance testing following the event(s).Intradialytic hypotension occurs in approximately 25% of all hd treatments, and is the most frequently observed complication of hd therapy.Should additional information become available, the clinical investigation will be updated accordingly.

Event Description

A user facility biomedical technician (bmt) requested a service on a fresenius 2008k2 hemodialysis (hd) machine due to a patient coding during dialysis.It was reported that the patient¿s blood pressure dropped during treatment, the patient became unresponsive, and dialysis was discontinued.Follow-up with the in-patient services registered nurse (ipsrn) revealed that the patient was critically ill and hemodynamically unstable.The ipsrn reported the patient has a fully occluded artery (specifics not provided) and is not a candidate for a coronary artery bypass graft.During the reported event, the ipsrn was attempting to ultrafiltrate fluid from the patient when he ¿suddenly bottomed out¿ (specifics not provided).The hd treatment was discontinued; however, no additional information was provided.The ipsrn stated the patient remains hospitalized, however in the last 24 hours the patient has failed to tolerate dialysis (specifics not provided) on two occasions.The ipsrn stated the patient¿s condition is not improving, and he will likely become a do not resuscitate (dnr) following a family meeting.Additional details surrounding the patient¿s hospitalization were requested; however, the request was declined.The ipsrn reported the loss of consciousness was unrelated to the functionality of the 2008k2 hd machine.The ipsrn stated she was just following protocol when she requested the functional compliance testing and was not expecting any findings.A fresenius regional equipment specialist (res) completed functionality checks on the machine based upon the temperature and conductivity settings used during the reported treatment.All functionality tests passed.Additional patient, event, and hospitalization information was requested, but the ipsrn declined to provide.

Manufacturer Narrative

Plant investigation: a on-site evaluation was performed by a fresenius regional equipment specialist (res).The res completed functionality checks on the machine using temperature and conductivity settings used during the patient treatment.The res verified the machine passed all functionality checks.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.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8332610
• MDR Text Key: 135934932
• Report Number: 2937457-2019-00465
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR