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

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

Patient Problems Myocardial Infarction (1969); Hypervolemia (2664)

Event Date 05/03/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient and their caregiver reported the patient experienced drain complications with the liberty cycler.Patient's caregiver asked technical service how to perform manual treatments.Follow up with the patient's peritoneal dialysis registered nurse (pdrn) indicated the patient was later hospitalized for what is believed to be fluid overload.The pdrn stated the patient's caregiver was no longer providing the patient with assistance with peritoneal dialysis and the patient did not know how to perform dialysis treatments.The patient was diagnosed with acute myocardial infarction but refused treatment from the hospital.The patient has a borderline personality disorder which exacerbated the clinics ability to ensure the patient receives proper dialysis treatment.Patient is currently in the hospital.Patient medical records have been requested.

Manufacturer Narrative

Please note: this is a followup acknowledging that this event was a duplicate of an event sent under original mdr submission number 2937457-2016-00496.No further submissions will be submitted against mdr 2937457-2016-00542.

• 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: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5679738
• MDR Text Key: 45962008
• Report Number: 2937457-2016-00542
• 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: consumer,health professional
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 73 YR