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

Catalog Number RTLR180111

Device Problems Use of Device Problem (1670); Device Issue (2379)

Patient Problems Dyspnea (1816); Hypervolemia (2664)

Event Date 06/25/2017

Event Type  Injury  

Manufacturer Narrative

A follow up will be submitted following evaluation.

Event Description

A peritoneal dialysis (pd) patient's contact reported the patient was in the hospital (b)(6) 2017 and was requesting a replacement cycler as the patient had been unable to complete treatment using the cycler for 2 days.The cycler had alarmed for air detected in the cassette and scale reading errors.The cycler had just been replaced recently and no treatment had been able to be completed on the current cycler.During follow up the patient's pd nurse reported that the patient was not able to complete treatment with the cycler and did not switch to manuals for 3 days resulting in hypervolemia and dyspnea.The patient was admitted to the hospital where the patient was dialyzed on the hospital cycler (unknown dates).Per the nurse the patient does not do manuals at home.Note that all pd patients are trained on manuals and how to perform them.The cycler was replaced.Additional information has been solicited but not made available.

Manufacturer Narrative

The cycler was returned for evaluation.A visual inspection of the returned cycler exterior showed no signs of physical damage.During the simulated treatment a scale reading alarm was encountered.The failure was caused by the heater tray making contact with the liberty top cover.The heater tray was adjusted and testing was continued.The simulated treatment was performed and completed without any failures or problems.The programmed displayed fill values were within tolerance.There were no visual indications of dried fluid within the cassette compartment.

Manufacturer Narrative

Plant investigation: an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Should additional relevant information become available, a supplemental report will be submitted.Clinical review: a clinical investigation was performed to identify a causal relationship between the patient's peritoneal dialysis (pd) treatment and the event of fluid overload and shortness of breath.The reported documentation suggests a possible causal relationship between the adverse events and the liberty cycler not functioning correctly.The product investigation activity confirmed a heater tray malfunction.The patient continued ccpd therapy during hospitalization but it is unknown if fresenius products were used.A temporal relationship between the patient's pd treatment and the fluid overload and shortness of breath remains.Should additional new information be made available this clinical investigation will be reevaluated.

Event Description

".".

• 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: 6732489
• MDR Text Key: 80694666
• Report Number: 2937457-2017-00608
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• 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: 07/11/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR