MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

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

Patient Problems Dehydration (1807); Electrolyte Imbalance (2196)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A supplemental report will be submitted upon final review of medical records by post market clinical physician and completion of the plant¿s investigation.

Event Description

A peritoneal dialysis (pd) patient's caregiver called and reported the patient was in the hospital for dehydration and low sodium levels.Follow-up with the patient铠nurse confirmed the patient was admitted to the hospital for dehydration and migraine related issues.She could not offer a specific date but indicated the patient was still in the hospital in stable condition.She could not offer details related to dialysis vintage or patient age but stated the patient uses 1.5% delflex.She further stated pd treatments (or products) were not related to the patient's dehydration/migraine/sodium event(s).She stated the patient had not been administered the product at the onset of the event.She stated the patient continues to perform pd therapy in the hospital.

Manufacturer Narrative

The complaint device is unavailable for failure analysis investigation as the serial number is unknown.All device history records (dhr) are reviewed and released according to ¿dhr review checklist & release procedure¿, a device is not released if it does not meet requirements or is nonconforming.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5930005
• MDR Text Key: 53966759
• Report Number: 2937457-2016-00946
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

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 Catalogue Number: RTLR180111
• Other Device ID Number: UDI: 00840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2016
• Initial Date FDA Received: 09/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/22/2016
• 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
• Treatment: DELFLEX PD SOLUTION; LIBERTY TUBING
• Patient Outcome(s): Hospitalization