MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICAN LIBERTY CYCLER SET, DUAL PATIENT CONNECT

Catalog Number 050-87212

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 03/14/2014

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

Review of patient medical records indicate the patient was diagnosed with peritonitis on (b)(6) 2014.No further information was provided.

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, DUAL PATIENT CONNECT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICAN; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5353183
• MDR Text Key: 35517876
• Report Number: 8030665-2016-00001
• 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,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2016
• 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): Required Intervention
• Patient Age: 68 YR