MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER UL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY CYCLER UL

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

Patient Problem Uremia (2188)

Event Date 04/01/2018

Event Type  Injury  

Manufacturer Narrative

A probable temporal relationship exists between ccpd therapy with the liberty cycler and the reported event(s) of elevated creatinine and blood urea nitrogen.However, there is no documentation or indication the liberty cycler caused or contributed to the event(s).The etiology for the increase in creatinine and blood urea nitrogen is unknown.Additionally, the liberty cycler is not available for product investigation.Therefore, based on available information, it cannot be concluded if the liberty cycler caused or contributed to the event(s).The alleged event is not confirmed.The device was not returned to the manufacturing plant.The serial number is unknown, therefore a device history review could not be performed.

Event Description

During a routine social medical check, it was reported by a peritoneal dialysis patient contact that an unknown peritoneal dialysis patient was using an unknown model of liberty cycler and that the treatment is not working well.It was reported that the patient was in hospital for 3 weeks and suffers from type 2 diabetes and leukemia in addition to kidney failure.Hospitalization date is unknown.Patient contact stated that the patient takes medication for these health concerns and is on ¿phos¿ binders.Patient contact also reported that patient¿s creatinine and urea levels have become elevated while using the liberty cycler.

• Brand Name: LIBERTY CYCLER UL
• 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: 7553041
• MDR Text Key: 109531826
• Report Number: 2937457-2018-01494
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER UL
• Device Catalogue Number: UNKNOWN- LIBERTY CYCLER UL
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/10/2018
• 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 SET; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention