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

Catalog Number 050-87216

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 02/07/2015

Event Type  malfunction  

Event Description

A peritoneal dialysis pt reported that dialysis solution leaked out of his catheter.Upon follow up, the pdrn stated that leak was not coming from his pd catheter but was coming from the extension set.Pdrn stated that there was a tear in the extension set and the stay safe cap was off when the pt went into the clinic.The cap had fallen off.Prophylactic antibiotics were administered and there was no other known pt ill effect.Pt's effluent remained clear.Sample is not available for return.

Manufacturer Narrative

The 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 within three months of the date of the event.Batch records for the lot identified were reviewed adn confirmed there were no deviations or nonconformances during the mfg process.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT.DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MFG; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331; parque industrial reynosa; reynosa, tamaulipas, cp 8878 0
• Manufacturer Contact: tanay taft, rn cnor ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4597317
• MDR Text Key: 5485101
• Report Number: 8030665-2015-00109
• 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,User Facility,Company Representative
• Type of Report: Initial
• Report Date: 02/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2015
• Initial Date FDA Received: 03/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: PD SOLUTIONS; LIBERTY DIALYSIS CYCLER,