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 Problem Cardiac Arrest (1762)

Event Date 10/04/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  a temporal relationship exists between hd therapy utilizing the 2008k2 hemodialysis system, and the adverse event of cardiac arrest.Although the patient was connected to the 2008k2 hemodialysis system when the event occurred, there is no allegation indicating a fresenius product deficiency or malfunction caused or contributed to the patient¿s cardiac arrest.The occurrence of a cardiac arrest in hd patients is low considering the complex nature of the procedure.However, given the results of the functional compliance testing and the absence of treatment records and/or hospitalization summary; the 2008k2 hemodialysis system cannot be excluded from having a possible causal or contributory role in the patient¿s cardiac arrest, as there is insufficient evidence to conclude causality.

Event Description

It was reported that a patient undergoing hemodialysis (hd) for renal replacement therapy coded during treatment.Follow-up with the inpatient program manager (ipm) confirmed the patient suffered a cardiac arrest and coded during hd therapy (specifics not provided).Additional information was requested (e.G.Treatment records, past medical history, concomitant medications and patient demographics), however the ipm declined the request.Functional compliance testing was ordered for the 2008k2 hemodialysis system following the event.A regional equipment specialist performed testing on the machine.The ultrafiltration (uf) pump strokes were elevated and out of range.The pumps were recalibrated.The machine completed operation verification.The machine was not returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A fresenius field service technician (fst) performed an on-site inspection of the machine.The ultrafiltration pump strokes were found to be elevated.The fst resolved the issue by calibration the ultrafiltration pump.The machine went through a self-test with no issue.The machine passed testing and functional tests.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.

• 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: 9187065
• MDR Text Key: 162286819
• Report Number: 2937457-2019-03168
• 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: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• 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: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention