MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

Model Number LIB

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

Patient Problem Hernia (2240)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

All information available to the manufacturer has been provided.

Event Description

A peritoneal dialysis (pd) nurse reported a patient on a liberty cycler using continuous cycling peritoneal dialysis (ccpd) underwent hernia repair on (b)(6) 2015.The nurse stated the patient recently discovered they had hernia.The nurse further stated the patient was doing well and performing treatments and has not reported any new complications.No further information was provided.

Manufacturer Narrative

Based on the review of medical records, this (b)(6) white male esrd patient on continuous cycling peritoneal dialysis (ccpd) therapy started dialysis therapy on an unknown date in (b)(6) 2015.On (b)(6) 2015, the patient underwent a laparoscopic right inguinal hernia repair with mesh to address a symptomatic inguinal hernia.Hernias are usually caused by high intra-abdominal pressure on a weak point of the muscular layers that make the abdominal walls.There are many factors associated to the risk of abdominal hernia in peritoneal dialysis patients with end-stage chronic disease.The instillation of dialysis fluid into the peritoneal cavity is accompanied by an increase in intra-abdominal pressure and this increase can lead to a variety of mechanical complications.At the time of this review, there is no clinical information that could allow us to analyze a temporal association between the herniorraphy adn the peritoneal dialysis process, due to the fact that it is unknown if the patient experienced the right inguinal hernia prior to renal replacement therapy initiation, or if the hernia was pre-existing condition that was exacerbated by the pd therapy.All information available to the manufacturer has been provided.

Manufacturer Narrative

As per solution, cycler was not replaced; therefore no physical investigation was performed on the device.As of date, no further info about the device has been provided by the customer.The device history record (dhr) was reviewed on 01/26/2016.According to the last dhr entry dated 11/06/2015, there were no noted issues relating to the current reported power fail recovery failed and dc drain complication encountered issues.An investigation of the device mfg records was conducted by the mfr.There were no deviations or non-conformances during the mfg process.In addition, the device record review confirmed the labeling, material, and process controls were within spec.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 8006621237
• MDR Report Key: 5346739
• MDR Text Key: 35244062
• Report Number: 2937457-2015-01768
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 86