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

Catalog Number RTLR180111

Device Problem Device Issue (2379)

Patient Problem Hypervolemia (2664)

Event Date 06/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient called to report that the cycler is not draining him properly.The cycler is leaving him with negative uf's, he is extremely bloated and feels pressure around his lungs.The cycler was replaced at this time.A follow up call was made to the patient's nurse who reported that the patient experienced a fluid overload and was admitted to the hospital.The patient was given peritoneal dialysis therapy while in the hospital with 4.25% solution to attempt to remove the fluid.This did not work as the patient has membrane failure.The patient has been transitioned to hd therapy.

Manufacturer Narrative

Although a temporal association with the adverse events of bloating and fluid overload and the liberty cycler exists, there is no documentation to show a causal relationship.During the course of the hospitalization it was found that the patient had a (peritoneal) membrane failure which would cause the symptoms of bloating and pressure around the patients¿ lungs.As a result of the membrane failure the patient was transitioned to hd for rrt.The cycler was received for evaluation.The simulated treatment was performed and passed without issue.The system air leak passed.Cycler passed valve actuation testing without issues.In addition, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.

• 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: 6725362
• MDR Text Key: 80453564
• Report Number: 2937457-2017-00597
• 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: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• 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: 06/28/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2014
• 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: DELFLEX PD SOLUTION; LIBERTY TUBING
• Patient Outcome(s): Hospitalization; Required Intervention