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

Catalog Number 050-87216

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

Patient Problem Peritonitis (2252)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.Device review: the device was not returned to the manufacturer for physical evaluation.The customer was unable to provide the manufacturer with the lot number of the product used in the reported event.As no lot number was provided by the complainant, a record review was performed on each of the lot numbers shipped to the complainant in the three months leading up to the reported event.The record review found 2 lot numbers shipped to the customer during that time period.The batch production records for these lots were reviewed.The batch records confirmed that released product met specifications; and documented manufacturing process controls were within specifications.Per the documented product investigation, there was no indication that the fresenius product caused, contributed to or was a factor in the reported event.

Event Description

Another manufacturer reported a peritoneal dialysis (pd) patient "kept getting peritonitis" while using fresenius products.It was noted the patient switched to another manufacture's products and have not had any problems.No further information was provided.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT.DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT, ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas. cp 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5224929
• MDR Text Key: 31336791
• Report Number: 8030665-2015-00513
• Device Sequence Number: 1
• Product Code: FKC
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/10/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR