MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 050-87216

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

Patient Problem Peritonitis (2252)

Event Date 03/03/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 plant¿s investigation.

Event Description

A peritoneal dialysis (pd) patient's spouse called to report the patient experienced drain complications during treatment.Follow-up with the patient's peritoneal dialysis registered nurse (pdrn) indicated the patient was hospitalized on (b)(6) 2016 for peritonitis of an unknown cause.The patient was treated with antibiotics and discharged on (b)(6) 2016.Medical records have been requested.

Manufacturer Narrative

Review of the medical records revealed the peritonitis was due to a peritoneal dialysis catheter infection.Any further follow-up required for this file will be submitted under mfr# 2937457-2016-00294.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; erika de reynosa; reynosa
• Manufacturer (Section G): REYNOSA; erika de reynosa, s. a. de c.; mike allen 1331 parque; reynosa, tamaulipas. cp
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5513768
• MDR Text Key: 40779536
• Report Number: 8030665-2016-00133
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/20/2016
• 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: Initial
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR