MAUDE Adverse Event Report: CONCORD MANUFACTURING UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number RTLR180111

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

Patient Problems Death (1802); Pneumonia (2011); Confusion/ Disorientation (2553)

Event Date 04/01/2017

Event Type  Death  

Manufacturer Narrative

Date of event set as (b)(6) 2017 as the exact date was not provided and unknown.Conclusion: based on the lack of patient historical information (medical/surgical history, comorbidities, medication regime) as well as reason for and course of multiple hospitalizations, a possible association (temporal or causality) between any fresenius products, liberty cycler and the adverse events of the pneumonia, altered mental status, the patient requiring transitioning to hemodialysis treatments on (b)(6) 2017 and subsequent patient expiration cannot be determined.Additional clinical information and the esrd death notification is needed to determine potential causality and determine the actual cause or secondary cause of this patient¿s death.Further information has been solicited the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

Source documents and information in the complaint file were reviewed by a post market surveillance clinician.On (b)(6) 2017 during a follow up call to the peritoneal dialysis registered nurse (pdrn) it was revealed this peritoneal dialysis (pd) patient with end stage renal disease (esrd) on ccpd therapy for unknown period of time had been frequently been hospitalized around (b)(6) 2017 as ¿the patient was going in and out of the hospital around this time due to an ongoing cold as well as mental issues.¿ the pdrn clarified that the reason for the hospitalization(s) was due to continuing pneumonia episodes and altered mental status (no specifics provided).The decision was made by the nephrologist/ pd clinic on (b)(6) 2017 to transition and place patient on in- center hemodialysis (hd) treatments with first hd treatment starting approximately around or after (b)(6) 2017.It is not known how the patient tolerated the hemodialysis treatments and unknown circumstances/events surrounding the patient¿s expiration (pdrn stated¿ the patient had since passed away.There was no known date of death in the complaint file and esrd death notification was requested.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• 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: 6746626
• MDR Text Key: 81149921
• Report Number: 2937457-2017-00633
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: RTLR180111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/03/2017
• Date Device Manufactured: 03/27/2017
• 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
• Treatment: LIBERTY CYCLER CASSETTE; PD SOLUTION
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention