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

Catalog Number RTLR180111

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

Patient Problem Hyperglycemia (1905)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi): (b)(4) - 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.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 (pd) patient's mother reported the patient was in rehab and stated the patient was currently in the hospital.Follow-up was made with the pd patient's clinic registered nurse (rn), who stated the patient was hospitalized for hyperglycemia on an unspecified date in (b)(6).She was not able to confirm that the hyperglycemia was due to diabetes management and not contributed to by the glucose in the pd solution.She also reported that the patient had been very sick for the past three months with peripheral vascular disease that affected his toes, fingers and penis.The patient decided to stop pd treatment on (b)(6) 2016 as a plan was made for him to enter hospice care.Medical records were requested.

• 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: 6209179
• MDR Text Key: 63409697
• Report Number: 2937457-2016-01260
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• 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: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2009
• 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: DELFLEX PD SOLUTION; LIBERTY CYCLER CASSETTE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR