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

Catalog Number RTLR180111

Device Problem Device Issue (2379)

Patient Problem Peritonitis (2252)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

The date of diagnosis was not made available the cycler was returned for evaluation.A visual inspection of the returned cycler exterior showed no signs of physical damage.During the simulated treatment an invalid sensor warning alarm for pump motor b alarm was encountered.The simulated treatment could not be completed.An accelerated stress test failed.Motor pump b began to stall and create noise.Pump b was replaced.There were no visual indications of dried fluid within the cassette compartment.This malfunction is not presumed to have caused or contributed to the patient's hospitalization for peritonitis, however the relationship could not be specified based on the information available.

Event Description

A peritoneal dialysis patient reported her cycler alarmed for invalid sensor readings.She was able to complete treatment.The cycler was replaced.During follow up on (b)(6)2017 the peritoneal dialysis patient's nurse reported the patient was hospitalized with peritonitis.During additional follow up on (b)(6) 2017 a second nurse reported the patient had been discharged and recovered.Additional information including specific dates of admission and diagnosis were solicited but the clinic declined to provide any additional information.

• 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: 6863895
• MDR Text Key: 86082194
• Report Number: 2937457-2017-00889
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• 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: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2014
• 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; Required Intervention