MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

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

Patient Problems Anemia (1706); Congestive Heart Failure (1783); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Pulmonary Dysfunction (2019); Heart Failure (2206); Hypervolemia (2664)

Event Date 04/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).There was no documentation that indicated a causal relationship between the liberty cycler or any fresenius products and the episode of fluid overload, acute exacerbation of diastolic congestive heart failure (chf) with moderate pulmonary hypertension, troponinemia, hypertensive episode and subsequent hospitalization.The patient's fluid overload was likely associated with the fluid balance management related to the patient¿s comorbidities, specifically esrd with anemia requiring blood transfusion and chf with an recent ejection fraction on cardiac echo of 65%, additionally validated by high brain natriuretic peptide; progressive elevation of troponin-1 levels and elevated creatine kinase-mb.The patient also had a positive urine drug screen for cocaine which may have been a contributory factor to the patient¿s presenting symptoms.The actual device was returned to the manufacturer for physical evaluation and the device operated out of specification.A visual inspection of the cycler exterior found the ¿heater button¿ was damaged and two cracks approximately 2.5¿ left and right of center on the top of the front panel ¿ bezel emi shield.No other physical damage was found.The simulated treatment was performed and completed without any failures or problems.The valve actuation test and the system air leak test passed.There was visual evidence of dried fluid under the left & right corners of the pump assembly and within the recess of the bottom cover adjacent to the pump.The cause of the observed dried fluid could not be determined.The patient sensor calibration check and the mushroom heads check.The load cell verification was within tolerance.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.

Event Description

It was reported by dialysis patient that patient had hard time breathing and was going to the emergency room on (b)(6) 2017.Patient's peritoneal dialysis registered nurse (pdrn) later reported that patient was hospitalized on (b)(6) 2017 due to mild fluid overload.Upon the review of medical records the patient went to the emergency room (er) due to hard time breathing.In the er patient additionally complained of low back pain, headache, and despite taking antihypertensive medication in the morning, blood pressure was reported as high as 202/123.Patient was treated with catapres and morphine.In the hospital the impression and the plan were identified in the medical records as follows: acute exacerbation of diastolic congestive heart failure (chf) with moderate pulmonary hypertension, diuresis with lasix 80 mg intravenous (iv).Cardiac echo performed in (b)(6) 2017 results showed ejection fraction of 65% and moderate pulmonary hypertension.Patient was positive for cocaine and this could have been the possible exacerbating cause of chf episode, and continued to trend troponin levels every 4 hours as the results are higher than patient¿s baseline troponin level.Patient was denying experiencing any chest pain and currently was not requiring supplemental oxygen.It is noted in the medical records that troponinemia could be due to chf exacerbation.Iron deficiency anemia had been assessed and it was determined that the patient required transfusion with 2 units packed red blood cells for a goal of 9 ( hemoglobin) in a dialysis patient.Additionally physician ordered lasix 20 mg iv in between transfusions.Patient continued on pd therapy while hospitalized.Patient¿s symptoms of chf and headache could be directly related to the hypertensive episode.Computerized tomography (ct) scan of head was ordered to evaluate etiology of patient¿s headache.During the hospitalization patient continued to complete pd treatments on the hospital cycler with or without issues.Patient¿s pdrn later reported that patient was discharged from the hospital on (b)(6) 2017.Patient¿s pdrn stated there was resolution of the pleural fluid and lungs were clear and patient was continuing continuous cycling peritoneal dialysis (ccpd) therapy.Patient¿s pdrn stated it was unknown if the hospitalization was related to the cycler or ccpd treatment.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6561537
• MDR Text Key: 74961498
• Report Number: 2937457-2017-00356
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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
• Treatment: CATAPRES; COREG; DELFLEX PD SOLUTION; HYDRALAZINE; LIBERTY CYCLER SET; MINOXIDIL; PHOSLO; RENVELA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 93