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

Catalog Number RTLR180111

Device Problem Use of Device Problem (1670)

Patient Problem Electrolyte Imbalance (2196)

Event Date 06/11/2017

Event Type  Injury  

Manufacturer Narrative

A follow up mdr will be submitted upon completion of the plant's investigation.

Event Description

A peritoneal dialysis patient called tech services to find out where her replacement cycler was.The patient reported that she was in the hospital for two weeks and just got home.Follow up information was received from the patient's nurse.The nurse reported that the patient was admitted to the hospital for hyperkalemia following a dialysis "strike".The nurse reported that the patient stopped doing her peritoneal dialysis on (b)(6) 2017 which led to the patient being admitted to the hospital.The patient had informed the nurse that she would not do dialysis due to having a refurbished machine that alarms.The patient was offered a replacement cycler, but declined.The patient was also instructed to call tech services to discuss the alarms, but she also refused to do this.The patient received a new cycler upon discharge from the hospital.The patient's nurse reported that she set the patient's cycler up when the new one was delivered.The patient was noted to be non compliant with therapy.

Manufacturer Narrative

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 nonconformances during the manufacturing process.There is no documentation in the complaint file to support a temporal or causal association between the liberty cycler and the patient experiencing hyperkalemia requiring subsequent hospitalization.The patient¿s adverse event is attributed to patient non-compliance (declining to perform dialysis treatments at home) beginning 9 days prior to the hospitalization 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: 6727601
• MDR Text Key: 80513201
• Report Number: 2937457-2017-00602
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• 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?: No
• Device Age: MO
• Date Manufacturer Received: 07/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2009
• 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
• Treatment: DELFLEX PD SOLUTION; LIBERTY TUBING