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

Catalog Number RTLR180111

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

Patient Problems Dyspnea (1816); Fatigue (1849); Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Abdominal Distention (2601)

Event Date 04/13/2014

Event Type  Injury  

Event Description

A nurse reported that a patient was hospitalized on (b)(6) 2014, due to shortness of breath and fatigue.Upon admission, the patient was also found to be in a hyperosmolar hyperglycemic state, with a blood glucose result of 1047, a blood pressure 220/120, and abdominal distension.The nurse stated that the patient's abdominal distension was due to drain complications associated with the peritoneal dialysis catheter.On an unknown date in (b)(6) 2014, the patient was discharged from the hospital.On (b)(6) 2014, the patient underwent a peritoneal dialysis catheter extraction and discontinued peritoneal dialysis therapy.As of (b)(6) 2014, the patient started and continues in-center hemodialysis therapy without any further issues, the patient's complaint of shortness of breath and fatigue has resolved, the patient's hyperosmolar hyperglycemic state has resolved to a blood glucose level within normal limits, and the patient's complaint of abdominal distension has resolved.

Manufacturer Narrative

Based on the information provided, it is unknown how the device may have caused or contributed to the event.The post market surveillance department has reviewed medical records and investigations are pending.Medical records were received and reviewed by the post market surveillance department.The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Manufacturer Narrative

The patient's medical records were received and a clinical investigation was completed.The clinical investigation concluded that there was no report of device malfunction or the device being out of specification.The patient's elevated blood glucose level was thought to be the result of a malfunctioning pd catheter and poor drainage of the pd fluid.The device was not returned to, he manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within spec.

Manufacturer Narrative

The serial number of the device not available.The cycler was not replaced.Information was documented.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 7816999000
• MDR Report Key: 4128174
• MDR Text Key: 16557575
• Report Number: 2937457-2014-02782
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2014
• 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: DAILY); CALCIUM CARBONATE ANTACID PER OS (TAKE BY MOUTH); DAILY); SODIUM BICARBONATE 650 MG TABLET (1 TABLET BY; MOUTH DAILY); CALCITRIOL 0.5MCG CAPSULE (1 CAPSULE BY MOUTH; TWO TIMES DAILY); NIFEDIPINE XL 60MG 24HR TABLET (1 TABLET BY MOUTH; LISINIPRIL PER OS; LABETALOL 200MG TABLET (1 TABLET BY MOUTH TWICE; MINOXIDIL 10MG TABLET (1 TABLET BY MOUTH DAILY); DELFLEX PD SOLUTION
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 50 YR