MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY DIALYSIS CYCLER

Device Problem Partial Blockage (1065)

Patient Problem Peritonitis (2252)

Event Date 05/17/2014

Event Type  Injury  

Event Description

A peritoneal dialysis patient has reported that they received a patient line blocked message during treatment.Patient checked the clamps, connection, and for kinks and stated that everything looks fine.Upon follow up with patient, he stated that he re-set up with new supplies and was able to complete treatment the next morning.Patient stated he was admitted to the hospital on (b)(6) 2014, for stomach pains and was diagnosed with peritonitis.The nurse confirmed that the patient was admitted to the emergency room on (b)(6) 2014 and had pain, cloudy fluid and his rbc was elevated.Doctor administered antibiotics and the patient's cultures were negative.Nurse stated the patient is now fine.Sample has not been returned to the manufacturer.

Manufacturer Narrative

Medical records have been received by the manufacturer.At the conclusion of the investigation, a supplemental report will be filed with the results of the clinical and plant investigations.Related mdr: 8030665-2014-00479.

• Brand Name: LIBERTY DIALYSIS CYCLER
• Manufacturer (Section D): CONCORD MANUFACTURING; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451 ; 8006621237
• MDR Report Key: 3919100
• MDR Text Key: 17282213
• Report Number: 2937457-2014-01047
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• 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
• Date Manufacturer Received: 05/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: LIBERTY DIALYSIS TUBING
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 54 YR