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 Hyperglycemia (1905); High Blood Pressure/ Hypertension (1908); Urinary Tract Infection (2120); Electrolyte Imbalance (2196); Hypervolemia (2664); Dysuria (2684)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon final review of medical records by post market clinical and completion of the plant's investigation.

Event Description

The peritoneal dialysis (pd) patient requested a replacement cycler due to draining complications on the liberty cycler.The patient stated he was hospitalized due to swelling.During a follow-up, the pd registered nurse (rn) stated the patient had only dialyzed seven times for the entire month of november.The patient was hospitalized on (b)(6) 2015 and discharged on (b)(6) 2015.The patient had a blood sugar level of 1290 upon his hospitalization.The pdrn believes the patient was not taking his insulin and being non-compliant.The patient had received a replacement cycler and continued pd treatment without any problems.The patient's medical records revealed the patient presented in the hospital with mild dysuria.Hypertension with confusion, and presence of abdominal fullness.During the patient's hospital stay, he was temporarily transferred to hemodialysis until his release.

Manufacturer Narrative

External, visual inspection: a visual inspection of the returned cycler exterior showed no sign of physical damage.The heater tray/scale was not obstructed 3.The simulated treatment was performed and completely without the failures.The valve actuation test passed.The system air leak test passed.The load cell value and verification was within tolerance.The patient sensor calibration check passed.There were no discrepancies encountered in the internal inspection of the cycler.In addition, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.The batch record review confirmed the labeling, material, and process controls were within specification.Based on the 25 pages of medical records information it appears that this (b)(6) white male esrd patient on renal replacement therapy being carried out via continuous cycling peritoneal dialysis (ccpd) therapy, started dialysis therapy on an unknown date.The patient under study is on medication for diabetes mellitus.The frequency of diabetes mellitus in end stage chronic renal failure patients is high.Diabetes is one of the main causes of chronic kidney disease, and of the progression of the disease until patients need kidney replacement therapy.There is no documentation in the medical record supporting a possible association between the liberty cycler and the reportable events.Further information has been solicited.

Event Description

On (b)(6) 2015, the patient presented to a hospital's emergency department with 2+ bilateral lower extremity edema, a glucose serum result of 1241, was diagnosed with hyperosmolar hyperglycemic nonketotic syndrome, and was admitted to an intensive care unit.On (b)(6) 2015, the patient was diagnosed with a urinary tract infection via a positive urinalysis and rocephin (ceftriaxone) 1gm daily via intravenous (iv) route was initiated.On an unknown date after being admitted, the patient underwent placement of a non-tunneled right internal jugular hemodialysis (hd) catheter, the patient's treatment modality was changed from pd to hd, for an unknown reason.On an unknown date during the admission, the patient experienced an event of hyperosmolar hyperglycemic coma and encephalopathy.A progress note from (b)(6) 2015 revealed that the patient's glucose readings ranged between 70-170 with a low rate insulin drip, the event of confusion resolved with a level of consciousness alert and oriented times three, no neurological deficits, and the event of hyperglycemic hyperosmolar coma and encephalopathy resolved.As of (b)(6) 2015, the patient's treatment modality was changed back to pd, the hd catheter was removed, event of bilateral lower extremity edema decreased to 1+, the patient responded symptomatically to the rocephin prescribed to address the event of urinary tract infection, and the patient was discharged from the hospital.

• 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: 5331911
• MDR Text Key: 34734475
• Report Number: 2937457-2015-01726
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 12/23/2015

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: 00840861100972
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2015
• 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): Hospitalization
• Patient Age: 58 YR