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 10/06/2016

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi): (b)(4) - a follow-up mdr will be submitted following evaluation.There is no allegation of device malfunction and the association with the event of peritonitis.There is no documentation in the medical record supporting a possible association between the liberty cycler and the event of peritonitis.However, there is a probable association between breaking the aseptic technique of pd therapy and peritonitis.

Event Description

A peritoneal dialysis (pd) patient reported draining slowly during drain 3 of 4.Follow-up with the patient's peritoneal dialysis nurse (pdrn) reveals that the patient experienced peritonitis, which the pdrn attributed to touch contamination.The patient was prescribed and completed a course of the antibiotic ancef, the dose and route was not indicated.Patient is reported to be recovered.

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.

Event Description

A peritoneal dialysis (pd) patient reported draining slowly during drain 3 of 4.Follow-up with the patient¿s peritoneal dialysis nurse (pdrn) reveals that the patient experienced peritonitis, which the pdrn attributed to touch contamination.The patient was prescribed and completed a course of the antibiotic ancef, the dose and route was not indicated.Patient is reported to be recovered.

• 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: 6090274
• MDR Text Key: 59519968
• Report Number: 2937457-2016-01146
• 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: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• 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: 11/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2016
• 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: 66 YR