MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING LIBERTY CYCLER SET, SINGLE CONN/ECT DL

Catalog Number 050-87216

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/05/2015

Event Type  malfunction  

Event Description

A peritoneal dialysis nurse (pdrn) reported that dialysis solution leaked out of the cassette and into the cycler.Nurse noticed leak immediately after treatment.Patient was able to complete treatment via manuals.Patient was administered prophylactic antibiotics and had no adverse effects.Patient's effluent remained clear.Sample has not been returned to the manufacturer.

Manufacturer Narrative

Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN/ECT DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331; parque industrial reynosa; reynosa, tamaulipas ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4804480
• MDR Text Key: 22159594
• Report Number: 8030665-2015-00265
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: 050-87216
• Device Lot Number: 13CR08817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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