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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dehydration (1807); Low Blood Pressure/ Hypotension (1914)

Event Date 07/09/2014

Event Type  Injury  

Event Description

The patient was hospitalized on (b)(6) 2014 due to dehydration, hypotension and failure to thrive.The patient's peritoneal dialysis nurse stated that the hospitalization was unrelated to dialysis treatment.The nurse confirmed the patient and his wife were both trained on performing stat drains as well as manual peritoneal dialysis therapy.The patient was discharged from the hosp on (b)(6) 2014.The patient continues to use continuous cycler-assisted peritoneal dialysis (ccpd) therapy with the cycler without any further issues.Med records have been requested.

Manufacturer Narrative

Based on the info provided, it is unk how the device may have caused or contributed to the event.The post market surveillance dept has requested med records and investigations are pending.A supplemental medwatch report will be submitted when medical records are received.The device was not returned to the mfr for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4059378
• MDR Text Key: 4808950
• Report Number: 2937457-2014-01934
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2014

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?: Yes
• Initial Date Manufacturer Received: 07/12/2014
• Initial Date FDA Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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 CYCLER CASSETTE; DELLFLEX PD SOLUTION
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 100