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

Model Number LIBERTY CYCLER UL

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypervolemia (2664)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: lack of sufficient information precludes a meaningful assessment in this case.However, it is known that inadequate or missed dialysis can lead to hospitalization; therefore, a possible causal relationship cannot be excluded due to the allegations against the device.Serial numbers for the liberty cyclers in question are unknown and the liberty cyclers are not available for manufacturer product investigation; therefore, it is unknown whether or not the liberty cyclers were performing according to specifications.Plant investigation: the alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.Since the serial number of the alleged device is unknown, a device history review could not be performed.

Event Description

On (b)(4) 2018, fmc rtg, llc received notification that on (b)(6) 2018 a patient (pt.) on continuous cycling peritoneal dialysis (ccpd) filed a voluntary medwatch (mw5077784) form for a serious injury allegedly related to the liberty cycler.The pt.Reported not being able to properly dialyze due to failure of two liberty cyclers while away from home at a conference.Upon return on (b)(6) 2018, the pt.Required emergency hospitalization to sustain life.Details surrounding patient demographics/information, hospitalization course and liberty cycler serial numbers are unknown.

• 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: 7689447
• MDR Text Key: 114019087
• Report Number: 2937457-2018-01976
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/11/2018,07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2018
• Device Age: MO
• Date Manufacturer Received: 06/22/2018
• 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