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

Catalog Number RTLR180111

Device Problem Device Inoperable (1663)

Patient Problem Hypervolemia (2664)

Event Date 01/21/2017

Event Type  Injury  

Manufacturer Narrative

Conclusion: there is documentation supporting a possible association between the liberty cycler and the event of excess fluid/fluid overload by the patient contact requiring emergency room care to be dialyzed (unknown amount of fluid removed) and a new liberty cycler.This was additionally confirmed by the patient on (b)(6) 2017.The pdrn stated the patient was possibly non-compliant and did not complete pd treatment for 2 days.The patient had originally reported on (b)(6) 2017 that he could not complete ccpd treatment on the cycler.An investigation of the device was conducted by the manufacturer.Exterior visual inspection showed no signs of physical damage.The voltage check and valve actuation tests passed.The system air leak test failed as the isolation valve was not working and the vacuum was not dropping.The cause is the bad isolation valve #27, which was replaced by production.

Event Description

The complaint file was reviewed by a post market surveillance clinician.It was reported that this peritoneal dialysis (pd) patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (ccpd) therapy presented at emergency room (er) on (b)(6) 2017 and subsequently hospitalized for fluid overload.On (b)(6) 2017, during a service call placed by the patient¿s contact the patient was experiencing issues due to having ¿ too much fluid¿ and was hospitalized.The patient contact claimed that it was cycler related and requested a new liberty cycler.During follow up call to the pd patient¿s clinic registered nurse (rn) on (b)(6) 2017 it was revealed the patient was taken to the emergency room (er) on saturday (b)(6) 2017 and was dialyzed there, and stated the patient's hospital stay was for less than 24 hours.Additionally, the pdrn stated the patient was non-compliant and had not completed ccpd therapy for 2 days in a row (unknown dates and reason) as well as time relationship to the er visit.On (b)(6) 2017 during a follow up call to the patient, it was revealed the liberty cycler wasn¿t functioning fine over the weekend of the event requiring hospitalization to complete dialysis treatment, and the patient stated he was discharged the following morning on (b)(6) 2017 and was able to complete ccpd therapy without issues.

• Brand Name: LIBERTY CYCLER
• 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: 6755136
• MDR Text Key: 81466499
• Report Number: 2937457-2017-00657
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• 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: consumer,health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 01/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2010
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 46 YR