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

Model Number LIBERTY CYCLER

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

Patient Problem Uremia (2188)

Event Date 10/28/2017

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 clinic director of admissions reported that a cycler is not working properly.The reporter stated that the patient was hospitalized due to the cycler malfunctioning.Upon follow up with the patient's nurse, it was noted that the patient was hospitalized for worsening uremia from (b)(6) 2017 - (b)(6) 2017.The nurse attributed the event to cycler malfunctioning.Treatment rendered at the hospital was unknown.Concomitant medications included calcitriol, carvedilol, culturelle, lantus, mucienx, oxycodone, famotidine, potassium chloride, procrit, renvela, and insulin glargine.The patient's peritoneal dialysis therapy remained unchanged and patient is still recovering as per patient's nurse.

Manufacturer Narrative

Device evaluation: the actual device was returned for investigation.A visual inspection of the returned cycler exterior showed no signs of physical damage.An (as-received) simulated treatment was performed and completed without failures.There were no fluid leaks in the test cassette during the test treatment.The system air leak test passed.The valve actuation test passed.The internal inspection showed that the front right, top cover cabinet post was broken off.There were no other discrepancies encountered in the internal inspection of the cycler.The device history record did not reveal any issues or problems related to the reported symptom code(s).Clinical investigation: a temporal relationship exists between the liberty cycler and the patient¿s hospitalization for uremia.While there is an allegation of a possible causal association between the liberty cycler and the patient¿s uremia, there is no documentation in the complaint file to support a causal relationship.The etiology of the uremia is unknown.

Event Description

A clinic director of admissions reported that a cycler is not working properly.The reporter stated that the patient was hospitalized due to the cycler malfunctioning.Upon follow up with the patient's nurse, it was noted that the patient was hospitalized for worsening uremia from (b)(6) 2017.The nurse attributed the event to cycler malfunctioning.Treatment rendered at the hospital was unknown.Concomitant medications included calcitriol, carvedilol, culturelle, lantus, mucienx, oxycodone, famotidine, potassium chloride, procrit, renvela, and insulin glargine.The patient's peritoneal dialysis therapy remained unchanged and patient is still recovering as per patient's nurse.

• 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: 7128104
• MDR Text Key: 95185295
• Report Number: 2937457-2017-01354
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• 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 FLUID
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR
• Patient Weight: 96