MAUDE Adverse Event Report: REYNOSA MANUFACTURING LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/06/2014

Event Type  Death  

Event Description

It was reported by the clinic that the patient expired while connected to peritoneal dialysis cycler.Cause of death was not reported.Also reported was that the patient had undergone coronary artery bypass and aortic valve replacement in (b)(6) of 2014 and had complications with sternal wound infections and required debridement surgery.The patient was admitted to the hospital again in (b)(6) of 2014 for sternal wound debridement.A picc line was inserted for antibiotics, the patient also developed thrombocytopenia and received blood transfusions for acute blood loss.She was discharged on (b)(6) 2014 to a rehab facility for her deconditioned state.

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 final review of medical records by post market clinical and completion of the plant's investigation.This product report is related to two other product reports for the same event.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamaulipas. cp 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4253182
• MDR Text Key: 5013633
• Report Number: 8030665-2014-00847
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K0403363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2014
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER, DELFLEX-PD SOLUTION
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Weight: 99