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

Model Number LIBERTY CYCLER

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

Patient Problems Uremia (2188); Confusion/ Disorientation (2553)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Event Description

Peritoneal dialysis patient nurse reported that the peritoneal dialysis patient was not dialyzing well and became uremic and confused.The patient was hospitalized on or about (b)(6) 2016.Additional information was solicited.

Manufacturer Narrative

The allegation is not confirmed.The liberty cycler serial number is unknown.An investigation of the product history review records was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.There is no documentation to show a causal relationship between the patient¿s hospitalization for confusion and uremia and the liberty cycler.Additionally, there are no reported allegations of a malfunction against the cycler.There is a probable temporal relationship between the confusion and uremia and the pd treatment.Insufficient or incomplete pd therapy will lead to an increase in uremia.It is unknown why the patient was experiencing insufficient pd therapy.

Event Description

During a routine follow up phone call on (b)(6) 2017 to the peritoneal dialysis registered nurse (pdrn) it was reported that this male patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) since (b)(6) 2013 had been hospitalized approximately a year prior for confusion.Per the pdrn the patient was not dialyzing effectively and was uremic which caused the confusion.It is unknown when the patient last had a treatment on the cycler prior to the hospitalization or if the patient continued peritoneal dialysis (pd) treatment while hospitalized.Hospital course unknown.The patient was transitioned temporarily to hemodialysis at that time.

• 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: 7058649
• MDR Text Key: 92912539
• Report Number: 2937457-2017-01252
• 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
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 52 YR