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

Model Number 190610

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

Patient Problem Death (1802)

Event Date 05/19/2020

Event Type  Death  

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 utilizing a 2008k2 hemodialysis system and the serious adverse event(s) of death.The patient reportedly expired while being transported back to their inpatient hospital room, following the completion of hd therapy.There is no allegation or objective evidence indicating a 2008k2 hemodialysis system deficiency or malfunction caused the patient¿s expiration.Nevertheless, the cause of the patient¿s death is unknown; therefore, causality cannot be definitively established.Dialysis patients continue to have significantly higher mortality, and fewer expected years of life when compared to the general population.Based on the totality of the information available, the 2008k2 hemodialysis system cannot be excluded from having a possible contributory role in the patient¿s expiration.Given the absence of a discharge summary, past medical history, esrd death notification, autopsy report, death certificate and no post-event device evaluation; there is insufficient evidence to disassociate the 2008k2 hemodialysis system.

Event Description

A user facility biomedical technician (biomed) reported to technical support (ts) that a patient expired after the completion of treatment on a fresenius 2008k2 hemodialysis (hd) machine.It was unknown if any alarms, diagnostic messages, or other issues were encountered during the treatment.The biomed inquired about whether there was a log of the patient's past treatments on the machine.The ts representative referred the biomed to the machine's debug screens which contain limited information.Follow up with the director of patient care services (dpcs) at the hospital revealed that the patient had expired while being transported back to their inpatient hospital room.Though multiple attempts were made to obtain additional information, no further details have been provided.

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).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; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10121708
• MDR Text Key: 194112694
• Report Number: 2937457-2020-00993
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death