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); Diarrhea (1811)

Event Date 08/22/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medical records were received from the patient's nurse which revealed that the patient was admitted to the hospital for dehydration and diarrhea.Per the medical records the dehydration was caused by the patient's diarrhea which was attributed to the patient being on antibiotics.The patient was given intravenous fluids.

Manufacturer Narrative

Based on the 45 pages of medical records information, it appears the (b)(6) female esrd patient on continuous cycling peritoneal dialysis (ccpd) therapy being carried out daily through delflex via intraperitoneal (ip) route with dose regimen not reported, that started dialysis therapy on an unknown date approximately 4.5 years ago.On (b)(6) 2016, the patient presented to a hospital status post 14 days of outpatient antibiotic treatment for peritonitis, with nausea, vomiting, diarrhea, and was admitted.During the admission on (b)(6) 2016, the patient was diagnosed with hypokalemia and dehydration.During the admission, the patient was administered intravenous fluids; drug names and dose regimens not reported; and potassium was replaced.As of (b)(6) 2016, the patient was discharged from the hospital, the hypokalemia resolved; the events of nausea, vomiting, diarrhea resolved; and the patient continues ccpd therapy.There is no documentation in the medical record supporting a possible association between the liberty cycler and the events.Further information has been solicited.

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device manufacturing review confirmed the labeling, material, and process controls were within specification.

• 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): WALNUT CREEK; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5983629
• MDR Text Key: 55826415
• Report Number: 2937457-2016-01028
• 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: other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2011
• 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: DELFLEX PD SOLUTION; LIBERTY TUBING
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 75