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 Death (1802); Myocardial Infarction (1969)

Event Date 12/15/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted technical services to request pick-up of a patient's liberty cycler and reported the patient had expired.Additional follow-up was made with the pdrn, who stated the patient had been hospitalized around 12/15/2015 due to a myocardial infarction.The patient was not dialyzing prior to the hospitalization event.The nurse stated the patient had a history of cardiac-related issues and stated the patient was transferred to a nursing home and subsequently expired on 01/08/2016.Medical records were requested.

Manufacturer Narrative

Corrected data: added patient's middle initial.Additional information: describe event or problem) due to a myocardial infarction.Medical records did not confirm this.Per pdrn the patient was not dialyzing prior to hospitalization.Pdrn stated the patient had a history of cardiac-related issues and was transferred to a nursing home and subsequently expired on (b)(6) 2016.Past surgical history: dialysis fistula creation; breast biopsy x2; cataract removal; dual chamber automatic implantable cardioverter-defibrillator.Allergies: latex, silver, ace inhibitors, angiotensin receptor blockers, bethanechol chloride, enalapril, lipitor, simvastatin, vasotec.Other: unique device identifier (udi).(b)(4).The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.Medical records were reviewed by post market surveillance staff.Medical records do not contain an autopsy report or death certificate for review.Medical records do not contain progress notes, lab/diagnostic results, medication records, dialysis flow records or physician orders for (b)(6) 2006 or at the time of death.Medical records do not mention if patient was on peritoneal dialysis at the time of death.The patient had a significant cardiac history that included a myocardial infarction, coronary artery bypass grafts and dual chamber automatic implantable cardioverter-defibrillator (that was placed (b)(6) 2015).The patient had several comorbidities including a right bundle branch block, cerebrovascular accident, coronary artery disease and hypertension.In addition, the patient had a recent hospitalization for osteomyelitis that included an amputation of three toes and angioplasty in the left lower extremity.There is no documentation in the medical record that indicates a causal relationship between the liberty cycler and the patient¿s death.There is no documentation in the medical record that indicates a causal relationship between the peritoneal dialysis solution and the patient¿s death.

Event Description

Medical records contained an end stage renal disease death notification indicating patient expired in a nursing home on (b)(6) 2016.Primary cause of death was cardiac arrest, cause unknown.Medical records revealed on (b)(6) 2015 the patient had chest pain during dialysis, resolved with nitro.On (b)(6) 2015 the patient again had chest pain, shortness of breath and nausea during her dialysis treatment, not resolved with nitro.On (b)(6) 2015 patient went to the hospital for evaluation and was found to have a troponin level of 0.862.Patient also complained her peritoneal dialysis (pd) catheter was possibly clogged and had a pre-existing condition of left leg cellulitis.She was taking levaquin for treatment and was started on intravenous antibiotics.Patient was admitted into the hospital for left leg cellulitis and malfunctioning pd catheter.During hospitalization the surgeon repositioned the pd catheter and broke up adhesions., restoring function.The patient's glucose was difficult to control due to overnight dialysate.Patient did not want to use her home insulin pump during hospitalization.Patient was seen by vascular surgeon for left foot cellulitis.On (b)(6) 2015 patient was given percutaneous transluminal angioplasty (pta) of the right superficial femoral artery (sfa) in the left lower extremity to restore antegrade blood flow.On (b)(6) 2015 patient had placement of a right internal jugular vein dual lumen groshong catheter.Because of the patient's osteomyelitis, the patient had an amputation of the 1, 2, 3 digits of left foot on (b)(6) 2015.The patient had 2 units of packed red blood cells for hemoglobin of 7.5.Patient improved and was discharged to a skilled nursing facility (b)(6) 2015.Patient's discharge diagnosis was osteomyelitis.Pd registered nurse (rn) stated the patient had been hospitalized around (b)(6) 2015.

• 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: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5390529
• MDR Text Key: 36817437
• Report Number: 2937457-2016-00095
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• 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?: Yes
• Date Manufacturer Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER CASSETTE
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 82