MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER SET

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 03/01/2013

Event Type  Injury  

Event Description

During review of medical records received on 12/15/2014 for an unrelated event, it was discovered that pt was hospitalized in (b)(6) 2013 for abdominal pain and peritonitis.Date and duration of hospitalization were not in the medical records.

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.Clinical investigation: based on the medical records info it appears that this pt had a hospitalization in (b)(6) 2013 for peritonitis.There is no documentation of treatment modalities for this hospitalization.Peritonitis is a known complication of peritoneal dialysis, caused by poor aseptic technique or a break in the sterile filed.There is no documentation in the medical record that indicates a causal relationship between the liberty cycler and the diagnosis of bacterial peritonitis.Based on the info provided, it is unknown how the device may have caused or contributed to the event.A follow-up mdr will be submitted upon completion of the device investigation.

• Brand Name: LIBERTY CYCLER SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; cd, reynosa, tamps ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa, s.a. de c.v.; parque industrial reynosa; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4425617
• MDR Text Key: 5413442
• Report Number: 8030665-2015-00020
• Device Sequence Number: 1
• Product Code: FKX
• 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,Consumer,Health Professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/15/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 01/15/2015
• 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
• Treatment: DELFLEX; LIBERTY CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 55