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

Catalog Number RTLR180111

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

Patient Problems Pneumonia (2011); Hypervolemia (2664)

Event Date 12/30/2015

Event Type  Injury  

Manufacturer Narrative

The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient reported he was hospitalized.Follow-up the patient's peritoneal dialysis registered nurse (pdrn) indicated the patient was hospitalized on (b)(6) 2015 for pneumonia.The patient experienced fluid volume overload which caused of the pneumonia.The patient was temporarily transferred to hemodialysis.As of (b)(6) 2016 the patient was still hospitalized.Medical records were requested.

Manufacturer Narrative

The device was not returned to the mfr for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device mfg records was conducted by the mfr.There were no deviations or non-conformances during the mfg 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 requirement or is nonconforming.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 ; 7816999000
• MDR Report Key: 5357033
• MDR Text Key: 35621573
• Report Number: 2937457-2016-00028
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2009
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR