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

Model Number LIBERTY CYCLER

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

Patient Problems Hernia (2240); Obstruction/Occlusion (2422)

Event Date 08/26/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer.A supplemental report will be filed upon completion of the manufacturer's investigation.

Event Description

A peritoneal dialysis patient's nurse reported that the patient had been hospitalized from (b)(6) 2017 for incarcerated bowel and hernia.The patient underwent surgery on the morning of (b)(6) 2017.The patient is still recovering from the surgery as the patient has a vertical mid line incision.The patient is currently not being treated by peritoneal dialysis therapy.The patient is being treated by flushing the toxins through a cv catheter and is doing fine.

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 non-conformance during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

Event Description

A peritoneal dialysis patient's nurse reported that the patient had been hospitalized from (b)(6) 2017 for incarcerated bowel and hernia.The patient underwent surgery on the morning of (b)(6) 2017.The patient is still recovering from the surgery as the patient has a vertical mid line incision.The patient is currently not being treated by peritoneal dialysis therapy.The patient is being treated by flushing the toxins through a cv catheter and is doing fine.

Manufacturer Narrative

Clinical evaluation: a temporal relationship exists between continuous circulatory peritoneal dialysis therapy with the liberty cycler and the exacerbation of the pre-existing incarcerated infraumbilical hernia which resulted in a small bowel obstruction, nausea, vomiting and diarrhea and subsequent laparotomy.Increased intra-abdominal pressure due to the dialysate can create or exacerbate pre-existing weakness in the supporting abdominal wall structures.A prior history of hernia and the placement of peritoneal dialysis catheter are risk factors for the increased likelihood of hernia formation.

Event Description

A peritoneal dialysis patient's nurse reported that the patient had been hospitalized from (b)(6) 2017 for incarcerated bowel and hernia.The patient underwent surgery on the morning of (b)(6) 2017.The patient is still recovering from the surgery as the patient has a vertical mid line incision.The patient is currently not being treated by peritoneal dialysis therapy.The patient is being treated by flushing the toxins through a cv catheter and is doing fine.

• Brand Name: LIBERTY CYCLER
• Type of Device: FKX - 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: 6901420
• MDR Text Key: 87653273
• Report Number: 2937457-2017-00971
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR18011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Event Location: Hospital
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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
• Patient Age: 68 YR
• Patient Weight: 92