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

Model Number 050-87212

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 07/24/2015

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.Culture revealed elevated white blood cells on (b)(6) 2015.Specific organism was not reported.There is nothing in medical records to say if fmc products contributed to this peritonitis.It cannot be concluded at this time what could have contributed to this peritonitis.Device evaluation: the complaint sample is not available and the lot number is unknown, thus a search of the lots delivered to the patient was conducted, with a time frame of three months before of the occurrence day.No product was available from this lot on distribution centers to be analyzed.The entire lot has been sold and distributed.Dhr review was performed on potential related lots.No nonconformance reports or other abnormalities during the assembly of these lots were found.The product involved met current specifications.

Event Description

A peritoneal dialysis nurse reported a patient was admitted into the hospital on (b)(6) /2015 due to abdominal pain and peritonitis was identified.The nurse stated the exact cause of the peritonitis is unknown.

Manufacturer Narrative

The system level review of the liberty cycler and concomitant products found no indication that the products caused or contributed in any way to this clinical event.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA
• Manufacturer (Section G): 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: 5041762
• MDR Text Key: 24627023
• Report Number: 8030665-2015-00384
• 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
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 07/28/2015

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 Model Number: 050-87212
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/14/2015
• 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 PD SOLUTION
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR