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

Catalog Number RTLR180111

Device Problem Leak/Splash (1354)

Patient Problems Uremia (2188); Confusion/ Disorientation (2553)

Event Date 07/29/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of plant's investigation.

Event Description

A peritoneal dialysis (pd) patent called on (b)(6) 2015 and reported a balloon valve leak for the past three nights during treatment.The patient reported completing some manual treatments and continuous ambulatory peritoneal dialysis (capd).During a follow up call the pd nurse stated the patient is a very large woman and is unsure if she completed an adequate amount of manual treatments due to her size.The nurse was unable to obtain specific information in regards to the manual treatments as the patient had become confused and disoriented.The pd nurse said the patient may be uremic due to potential partial treatments so they have scheduled three prophylactic treatments of in-clinic hemodialysis for the patient starting (b)(6) 2015.The pd nurse stated the patient went to the emergency room (er) on (b)(6) 2015 and was disoriented and instructed to return home and complete her peritoneal dialysis treatment.The patient was not admitted on (b)(6) 2015 and did not remain at the er for more than twenty four hours.

Manufacturer Narrative

The post market surveillance department reviewed the patient's medical records and the clinical investigation reveals the following: based on the 27 pages of medical records information, progress notes reveal the patient appeared confused during the (b)(6) 2015 home visit and she was unable to understand directions to disconnect her peritoneal dialysis.Patient's blood pressure was 212/116.The patient was unable to say who the president was and appeared disheveled with hair and clothing unkempt.The patient went to the emergency room on (b)(6) 2015 due to mumbling words and acting confused.The pdrn said that the patient may be uremic due to potential partial treatments so she was scheduled for three prophylactic treatments of in-clinic hemodialysis starting (b)(6) 2015.She confirms the patient was not admitted on (b)(6) 2015 and did not remain at the emergency room for more than twenty four hours.Medical records do not contain er progress notes, physician orders, history and physical, medication sheets, peritoneal dialysis medical history or treatment sheets.Patient was instructed to perform manual exchanges but admitted she was non-compliant.There is no documentation in the medical record that shows a causal relationship between the balloon leak and the patient's confusion and trip to the emergency room.The actual device was returned to the manufacturer for physical evaluation and determined to be functioning according to product specifications.A visual inspection of the returned cycler exterior showed no sign of any physical damage.A simulated treatment was performed and completed without any failures or problems.The valve actuation test and the system air leak test passed.There were no discrepancies encountered in the internal inspection of the cycler.A device manufacturing record review was conducted and confirmed there were no deviations or non-conformances during the manufacturing process.Product labeling, material, and process controls were within specifications.

Event Description

The following is from the patient's medical records provided by the treatment facility.Patient went to the emergency room with confusion and high blood pressure.Patient is a (b)(6) female who had a balloon valve leak on (b)(6) 2015, preventing her from completing her peritoneal dialysis treatment, she was instructed to complete manual exchanges.On (b)(6) 2015, the patient had a fluid leak when her cap fell off her transfer set and was given prophylactic intraperitoneal antibiotics to dwell but appeared to be confused.On (b)(6) 2015, the patient was confused and went to the emergency room.The patient was found to have an elevated blood pressure, 212/116 and confusion.According to the patient, she was unable to perform her dialysis on the machine because she was confused.The patient was also out of her medication.On (b)(6) 2015, the patient was scheduled for back up hemodialysis until it was decided if patient was coherent enough to perform her own peritoneal dialysis.The patient reported being non-compliant with her pd therapy and her prescribed medications.

• 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: 4995506
• MDR Text Key: 23085667
• Report Number: 2937457-2015-01318
• 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: Followup
• Report Date: 07/24/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/03/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 121