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

Catalog Number RTLR180111

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem Peritonitis (2252)

Event Date 12/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4) - a follow up mdr will be submitted following the manufacturer's evaluation.

Event Description

A peritoneal dialysis patient's caregiver reported that the patient was hospitalized for an infection.The patient's peritoneal dialysis nurse confirmed that the patient was hospitalized for peritonitis, caused by touch contamination.The patient's peritoneal dialysis nurse stated that laboratory results of the patient's dialysis effluent revealed the presence of staphylococcus epidermis, indicative of touch contamination peritonitis.The patient was administered the antibiotic vancomycin (route and dose unknown), recovered, and was discharged on an unspecified date.The patient has transitioned to hemodialysis.

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-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY CYCLER
• Type of Device: PERITONEAL DIALYSIS DELIVERY SYSTEM, AUTOMATED
• 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: 6214347
• MDR Text Key: 63608744
• Report Number: 2937457-2016-01268
• 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: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2009
• 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: LIBERTY CYCLER SET; PD FLUID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 106