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 Problem Uremia (2188)

Event Date 09/01/2017

Event Type  Injury  

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 a temporal association likely 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 patient¿s uremia, there is no documentation in the file to support a causal relationship between the liberty cycler and the patient¿s development of uremia.The etiology of the patient¿s uremia is unknown.The device was not returned to the manufacturer for physical evaluation, and the serial number was not able to be obtained to date.An investigation of the cyclers delivered to the customer for the product were reviewed and a serial number was not able to be determined.

Event Description

A follow up call with a peritoneal dialysis (pd) patient¿s nurse revealed the patient was hospitalized due to becoming uremic.The patient was hospitalized from (b)(6) 2017 and was diagnosed with uremia.The details of the hospitalization course are unknown.The patient has recovered from this event.Additionally, the pd nurse reported the patient has changed to baxter products to rule out any causal association between the patient¿s uremia and the liberty cycler.Starting on (b)(6) 2017 the patient has ceased use of fresenius products.The patient would be evaluated for another renal replacement modality should the patient continue to experience uremia on pd.

• 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: 6912591
• MDR Text Key: 88105399
• Report Number: 2937457-2017-00988
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention
• Patient Age: 30 YR