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

Model Number LIBERTY CYCLER

Device Problems Overfill (2404); Noise, Audible (3273)

Patient Problem Hypervolemia (2664)

Event Date 01/28/2018

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer.A supplemental report will be filed upon completion of the manufacturer's investigation.

Event Description

A peritoneal dialysis patient's contact requested assistance in bypassing on the cycler.The contact stated that the patient had returned home from the hospital and was empty.It was also reported that the cycler was noisy during drains.

Manufacturer Narrative

Device evaluation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.Clinical evaluation: a possible temporal relationship exists between ccpd treatment with the liberty cycler and the pt¿s chest pain, shortness of breath, cough and fatigue which required in-patient hospitalization where further testing revealed the presence of a large left pleural effusion warranting thoracentesis.However, there is no objective evidence contained in the complaint file that supports a causal relationship.The pt¿s chest pain may have been multi-factorial in nature due to concurrent anemia (known complication in esrd patients), large left pleural effusion, pulmonary hypertension and demand ischemia.Based on the available information, it cannot be determined what caused the pt¿s large pleural effusion (pleural fluid analysis results are unknown).At the time of this clinical investigation, there have been no reported allegations of a liberty cycler malfunction or deficiency associated with this event.The cause for the pt¿s incidental finding of hyponatremia during hospitalization is also unknown.Should additional information become available this clinical investigation will be re-evaluated accordingly.

Event Description

A peritoneal dialysis patient's contact requested assistance in bypassing on the cycler.The contact stated that the patient had returned home from the hospital and was empty.It was also reported that the cycler was noisy.Upon follow up with the patient's nurse, it was stated that the patient was hospitalized from (b)(6) 2018 - (b)(6) 2018 for fluid overload, which was possibly due to catheter malposition (not confirmed).The patient did not experience cycler issues.The patient was dehydrated few weeks prior to the event occurrence, therefore was using a lower strength delflex.The patient was well hydrated thereafter but continued using lower strength delflex which led to fluid overload.Treatment rendered at the hospital was removal of fluid.Peritoneal dialysis therapy continued with no further issues.

• Brand Name: UL 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: 7271542
• MDR Text Key: 100117850
• Report Number: 2937457-2018-00468
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Event Location: Home
• Date Manufacturer Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2011
• 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