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

Catalog Number RTLR180111

Device Problem Use of Device Problem (1670)

Patient Problem Peritonitis (2252)

Event Date 11/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A patient's contact reported he needed to discontinue treatment and take the patient to a hospital.During follow up the patient's peritoneal dialysis (pd) registered nurse reported that the patient was admitted to a hospital for peritonitis on (b)(6) 2016.The cause of the peritonitis was reported to be due to a breach in aseptic technique.The patient was administered antibiotic cefazolin (dosage and route unknown.) per physician order, the patient's pd catheter was removed and his dialysis modality was switched to hemodialysis.The patient recovered and was discharged from the hospital.

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation.However, 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 manufacturing review confirmed the labeling, material, and process controls were within specification.A clinical investigation was conducted.Although a temporal relationship between the diagnosis of peritonitis and the fresenius product exists, there is no documentation that indicates a causal relationship between the liberty cycler and this episode of peritonitis.Additionally, the peritoneal dialysis nurse stated that the peritonitis was likely related to a breach in aseptic technique and not related to the cycler.

• 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: 6136182
• MDR Text Key: 61153397
• Report Number: 2937457-2016-01195
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2011
• 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 SOLUTIONS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 61