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

Catalog Number (RTLR) 180111

Device Problems Delivery System Issue, No Description (2664); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypervolemia (2664)

Event Date 12/06/2015

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it is unknown how the device may have caused or contributed to the event.The post market surveillance department has requested medical records and investigations are pending.A supplemental report will be submitted upon completion of the plant's investigations.

Event Description

A peritoneal dialysis (pd) patient initially reported drain complication issues on (b)(6) 2015.Follow up with peritoneal dialysis registered nurse (pdrn) revealed the patient was a hemodialysis patient and they were attempting to try him on pd.The pdrn stated the patient was hospitalized on (b)(6) 2015 because of ultra-filtration failure due to fluid issues.The pdrn further stated the patient is out of the hospital no and is going to resume hemodialysis.

Manufacturer Narrative

A visual inspection was performed on the returned device and there were no signs of any physical damage with the received cycler.An internal inspection was performed and there were no discrepancies encountered in the internal inspection of the cycler.Simulated testing was performed and the device performed without failures.Device history review was performed and found no non-conformance reports or other abnormalities during the manufacturing process.The product involved met current specifications.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The complaint was not confirmed.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS USA, INC.; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tany taft, rn, cnor ; 920 winter st.; waltham , MA 02451-1457 ; 7816999000
• MDR Report Key: 5340399
• MDR Text Key: 35011119
• Report Number: 2937457-2015-01752
• 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: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: (RTLR) 180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Date Manufacturer Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2009
• 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