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

Catalog Number RTLR180111

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Date 10/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Event Description

Peritoneal dialysis patient reported that at approximately 3 weeks ago he had peritonitis because he disconnected a supply bag and switched the bags with the heater bag to clear a supply bags alarm.Patient stated that his pdrn already cleared his peritonitis.Follow up with the patient's peritoneal dialysis nurse (pdrn) confirmed that the patient was diagnosed with peritonitis due to the patient not following proper aseptic technique when performing peritoneal dialysis treatments.The patient was not hospitalized and was treated with vancomycin and has since recovered.

Manufacturer Narrative

The cycler was returned for evaluation.Exterior visual inspection showed signs of physical damage.The front panel bezel gasket was drooping approximately 1 inch over the center of the front panel overlay.The catch post does not align with cassette door, the catch post needed to be adjusted in production.The lcd screen was out of calibration, recalibrated the lcd screen.The plant performed a simulated treatment with the liberty cycler.Simulated treatments were completed without any failures or problems.System tests were performed and passed.There were no discrepancies encountered in the internal inspection of the cycler.In conclusion the allegation is not confirmed.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device record review confirmed the labeling, material, and process controls were within specification.

• 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: 6193846
• MDR Text Key: 62958058
• Report Number: 2937457-2016-01247
• Device Sequence Number: 1
• Product Code: FKX
• 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: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• 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: 12/28/2016
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2012
• 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 CYCLER CASSETTE
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 119