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 12/01/2015

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.A supplemental report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient initially reported trouble draining and a recent hospital discharge.During follow up with patient's peritoneal dialysis registered nurse (pdrn), it was learned the patient was hospitalized from (b)(6) 2015 for no-growth peritonitis, per pdrn, the patient received a 14 day course of unknown antibiotics and is recovering.The pdrn stated there had been no break in aseptic techniques or compromise of sterile pathway prior to diagnosis of peritonitis.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The complaint device lot number was not reported, however the sales and shipping records for the patient were reviewed for three months prior to the date of occurrence.No product was available from these lots in distribution centers to be analyzed, as the entirety of the lots have been sold and distributed.Device history review was performed on the potential related lots.No non-conformance reports or other abnormalities during the manufacturing process were found for these lots.The product involved met current specifications.In addition, the device record review confirmed the labeling, material, and process controls were within specification.The system level review of cycler device and concomitant products found no indication that the products caused or contributed in any way to the clinical event.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN. / EXT. DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA ; reynosa ; MX
• Manufacturer (Section G): ERIKE DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas, CP887 80; MX CP88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street ; waltham , MA 02451-1457 ; 7816999000
• MDR Report Key: 5340401
• MDR Text Key: 35009773
• Report Number: 8030665-2015-00612
• 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: consumer,user facility
• Type of Report: Initial,Followup
• Report Date: 03/28/2016

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: 12/03/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 87