MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NEWTON CYCLER

Model Number NEWTON

Device Problem Occlusion Within Device (1423)

Patient Problem Peritonitis (2252)

Event Date 12/31/2011

Event Type  Injury  

Event Description

It was reported by a patient/user of the fmc peritoneal dialysis (pd) liberty cycler that the patient acquired peritonitis and wanted to know if the fibrin in the lines was the cause of her slow drain.It was also reported that the patient was released from the hospital on two events prior to this for peritonitis.There were no reported cassette fluid leaks or device malfunctions and the facility peritoneal dialysis nurse believes that the use of the cycler did not cause or contribute to the peritonitis.

Manufacturer Narrative

Complaint investigation concludes the event is unlikely related to the fmc device.Clinical investigation indicates the peritonitis hospitalization event information was provided as relevant recent patient history.These events were not alleged to be related to the fmc device.These events predated the cycler complaint.The actual device was returned and no test was performed due to the device internally infested.Device received in condition making a product investigation impossible.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between march 21, 2011 to march 11, 2013.

• Brand Name: NEWTON CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 2637 shadelands dr.; walnut creek CA 94598
• Manufacturer Contact: 2637 shadelands dr.; walnut creek, CA 94598
• MDR Report Key: 4044101
• MDR Text Key: 4865070
• Report Number: 2937457-2014-02107
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Type of Report: Initial
• Report Date: 12/31/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NEWTON
• Device Catalogue Number: 18160300
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Weight: 36