MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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

Patient Problem Cardiac Arrest (1762)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An area technical operations manager (atom) at a user facility reported that a patient had a cardiac arrest during hemodialysis (hd) treatment while on a fresenius 2008t hd machine.There were no diagnostic messages or audible alarms.The atom stated that the patient was taken to the hospital and did not complete hd treatment.No further information regarding the patient status has been made available.There were no reported problems during the patient treatment prior to the event.Following the event, the machine was removed from service for evaluation by the user facility¿s atom.The atom ran simulated use testing and all functional and ultrafiltration testing on the machine and no problems were identified.The atom verified machine operations.No repairs were required.The machine remains out of service pending culture results.No defect or malfunction of any fresenius product in use during the hd treatment was observed or identified.No devices were stated to be available to be returned to the manufacturing plant for physical evaluation.

Manufacturer Narrative

See below clinical investigation: there is no documentation to show a causal relationship between the patient event of cardiac arrest and the 2008t hemodialysis (hd) machine.Additionally, there is no allegation of a machine malfunction.However, there is a temporal relationship between hd therapy on the 2008t machine and the cardiac arrest as the patient was completing treatment at the time of the event.Per the biomedical technician, the machine passed all testing after the event.It is unknown if the patient had comorbidities or was taking any medication that could have caused or contributed to the cardiac arrest.Based on available information, the cause of the cardiac arrest is unknown.

Manufacturer Narrative

A sample was not returned to the manufacturer for physical evaluation and the lot number or catalog number was not provided.Therefore, the complaint cannot be confirmed.A manufacturing review was performed on the lot numbers for all dialyzer products shipped to the customer for the three (3) month time frame which immediately preceded the event occurrence date.A records review was performed on the twelve lots identified by the manufacturer.Two lots had multiple approved temporary deviation notices (dn) and nine lots had a single approved temporary dn on each lot.All dns were unrelated to the reported complaint event.The review confirmed that there were no non-conformance, deviation, rework, or issues with labeling or process controls, or any other occurrence in production identified during the manufacturing process which could be associated with the reported event.Each of the twelve lots identified in this review passed pyrogen testing and were within the sterilization dosage parameters and passed all lot release criteria.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.

• Brand Name: DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 7265991
• MDR Text Key: 99885697
• Report Number: 1713747-2018-00055
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/13/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 04/09/2018
• Supplement Dates FDA Received: 03/07/2018; 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention