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

Model Number LIBERTY CYCLER

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

Patient Problems Pneumonia (2011); Hernia (2240)

Event Date 07/13/2017

Event Type  Injury  

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 patient's contact reported that while in drain 0, the cycler displayed a drain complication message.The contact reported that the patient had been in the hospital and was discharged on the day of this event.The patient's peritoneal dialysis nurse reported he patient was admitted to the hospital on (b)(6) 2017 for a lower gastrointestinal bleed, and discharged on (b)(6) 2017.While in hospital, it was noted that the patient was experiencing pneumonia, hiatal hernia, and hemoglobin drop.The patient was prescribed warfarin as an anticoagulant.The patient's dialysis prescription was increased to five times daily.The patient has been on peritoneal dialysis since (b)(6) 2016.

Event Description

A peritoneal dialysis patient's contact reported that while in drain 0, the cycler displayed a drain complication message.The contact reported that the patient had been in the hospital and was discharged on the day of this event.The patient's peritoneal dialysis nurse reported he patient was admitted to the hospital on (b)(6) 2017 for a lower gastrointestinal bleed, and discharged on (b)(6) 2017.While in hospital, it was noted that the patient was experiencing pneumonia, hiatal hernia, and hemoglobin drop.The patient was prescribed warfarin as an anticoagulant.The patient's dialysis prescription was increased to five times daily.The patient has been on peritoneal dialysis since (b)(6) 2016.

Manufacturer Narrative

There is no documentation to suggest a causal relationship between the event of lower gi bleed resulting in hospitalization and the liberty cycler.Additionally, there no allegation against any fresenius products and the adverse event.There is however a strong probable association to the patients¿ complex past medical history and the prescribed anticoagulant warfarin which was reported by the pd nurse but, not listed in the medication list assembled by the nephrologist.During the hospital course a 2cm sliding hiatus hernia was discovered in the esophagus during the egd testing for the gi bleed.However no intervention was required and it is unknown if the patients¿ pd therapy caused or contributed to the hernia.There is no documentation that shows a causal relationship between the event of 2cm sliding hiatus hernia and the liberty cycler.Although there is an association between the event of the hernia and the increase in intra-abdominal pressure that can occur during the normal course of pd therapy.

Event Description

A peritoneal dialysis patient's contact reported that while in drain 0, the cycler displayed a drain complication message.The contact reported that the patient had been in the hospital and was discharged on the day of this event.The patient's peritoneal dialysis nurse reported he patient was admitted to the hospital on (b)(6) 2017 for a lower gastrointestinal bleed, and discharged on (b)(6) 2017.While in hospital, it was noted that the patient was experiencing pneumonia, hiatal hernia, and hemoglobin drop.The patient was prescribed warfarin as an anticoagulant.The patient's dialysis prescription was increased to five times daily.The patient has been on peritoneal dialysis since (b)(6) 2016.

• 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: 6766458
• MDR Text Key: 81786358
• Report Number: 2937457-2017-00679
• 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: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Event Location: Home
• Date Manufacturer Received: 01/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2009
• 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; Other; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 96