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

Catalog Number RTLR180111

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

Patient Problems Nausea (1970); Vomiting (2144); Uremia (2188)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

A peritoneal dialysis (pd) patient¿s nurse called in regarding cycler replacement due to the patient becoming uremic.The technical support confirmed that the patient has been completing all treatments and receiving positive ultrafiltration.The technical support advised the pd nurse to use alternative treatment and replaced the cycler.During follow up the pd nurse reported the patient presented to the clinic with nausea and vomiting.The patient was hospitalized from (b)(6) 2017 and was diagnosed with uremia.The patient continued pd treatment unchanged and has received the new cycler.The patient did not have any signs of infection, their effluent remained clear, they were not fluid overload and they did not have ultrafiltration failure.The patient has recovered from the event.

Manufacturer Narrative

A clinical investigation was performed to identify a causal relationship between the peritoneal dialysis (pd) treatment and the adverse event.Based on the provided information there is a temporal association likely exists between the liberty cycler and the patient experiencing nausea and vomiting with subsequent inpatient hospitalization for uremia.Although there is an allegation against the liberty cycler; there is no documentation in the file to support a causal relationship between the liberty cycler and the patient¿s development of uremia.An investigation of the device was conducted by the manufacturer.There were no deviations or non-conformance during the manufacturing process.A visual inspection of the returned cycler exterior showed no sign of physical damage.Simulated treatment was performed and completed without any unexpected alarms or problems occurring.An interior inspection showed signs of dried fluid within the cassette compartment.There were no discrepancies encountered during the internal inspection of the cycler.The valve actuation test and the system air leak test passed.The record review confirmed the labeling, material, and process controls were within specification.There were no reported device malfunctions that would have caused the reported event.

• 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: 6846381
• MDR Text Key: 85087516
• Report Number: 2937457-2017-00840
• 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,Followup
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• 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: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2009
• 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): Required Intervention
• Patient Age: 30 YR