MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

Catalog Number 050-87216

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device was not returned to the mfr for physical eval, and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer over the past three months.A sap search found no product was available from this lot for eval.The device history record review performed on potential related lots revealed no non-conformances or other abnormalities.Product labeling, material, and process controls were within specification.

Event Description

A continuous cycling peritoneal dialysis (ccpd) pt's wife called technical support to report a cycler alarm during treatment and when she opened the cassette compartment door to re-setup with new tubing/supplies, fluid leaked out.Upon follow up with the pt's pd nurse, she stated that she was aware of the cassette fluid leak the pt experienced.She confirmed that no prophylactic antibiotics were given, the effluent remained clear, and there were no infections.There were no serous injuries as a result of this event.The pt remains with the ccpd program.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA ; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur, brecha e-99; apartado postal# 326; cd, reynosa, tamps 88780 ; MX 88780
• Manufacturer Contact: jerry succuro, ccht, ma ; 920 winter st. ; waltham, MA 02451-1457 ; 7816970376
• MDR Report Key: 5052716
• MDR Text Key: 24910026
• Report Number: 8030665-2015-00390
• 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
• Reporter Occupation: Other
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 050-87216
• Device Lot Number: 15DR08058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1