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

Catalog Number RTLR180111

Device Problem Device Issue (2379)

Patient Problems Dyspnea (1816); Fatigue (1849); Unspecified Infection (1930); Renal Disease, End Stage (2039); Uremia (2188); Electrolyte Imbalance (2196); Respiratory Tract Infection (2420); Shaking/Tremors (2515); Sleep Dysfunction (2517); Hypervolemia (2664)

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) - a supplemental report will be submitted upon the completion of the evaluation.

Event Description

A peritoneal dialysis (pd) patient's contact reported the patient was in the hospital because the patient's toxins were too high due to drain complication messages on the cycler resulting in not draining all the way.During follow up pd nurse stated that the patient had fluid overload and was hospitalized on (b)(6) 2017.The patient completed his treatment on the cycler and while in the hospital the extra fluid was removed and is continuing treatment on the hospital cycler without issues.

Manufacturer Narrative

There is no documentation supporting a possible association between the liberty cycler and the event of symptomatic uremia , which is an adverse event that is expected in the esrd pt population.Additionally, there is no documentation supporting a possible association between the fresenius products and the patient¿s presenting symptoms of generalized complaints of not feeling well, 2 month history of intermittent productive cough with clear sputum, shakiness, loss of appetite, increased sleepiness (fatigue) and subsequent hospitalization.The patient would have continued monitoring of ccpd therapy as well as the assessment of addition of mid-day exchange for improvement of creatinine clearance, and new prescription for home ccpd regime and dialysate strength.The actual device was returned to the manufacturer for physical evaluation.The cycler was released to production to be refurbished, no issues found.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.

Event Description

The complaint file and medical records were reviewed.It was reported that this patient with end stage renal disease (esrd), on continuous cyclic peritoneal dialysis (ccpd) therapy since (b)(6) 2016 had presented at emergency room (er) on (b)(6) 2017 and subsequently hospitalized for fluid overload.On (b)(6) 2017, during a service call placed by the patient contact, it was reported the patient was receiving frequent drain complication messages resulting in incomplete drains and requested a new liberty cycler.On (b)(6) 2017 during a follow up call to the registered nurse (rn) it was discovered the patient experienced fluid overload requiring inpatient hospitalization and treatment to have the extra peritoneal fluid removed.Additionally, the patient.Continued to perform ccpd therapy on the hospital¿s liberty cycler and completing treatment without issues.Review of medical records reveal patient admitted to the hospital on (b)(6) 2017 with generalized complaints of not feeling well, 2 month history of intermittent productive cough with clear sputum, shakiness, loss of appetite, increased sleepiness (fatigue) for past 2 months.Additionally, 4 months prior to admission patient had transitioned from hd therapy back to pd therapy.Patient states there have been no missed dialysis treatments and patient.Patient contact takes care of the ccpd therapy treatments on the liberty cycler at home, there has been no change in prescription since he started back on ccpd uses 1.5% alternating with 2.5% for 5 cycles.Medical record review reveals 12 point system review was benign and unremarkable except for the patient¿s present illness and symptoms, neuro exam noted tremors in the lower extremities: baseline vital signs were: blood pressure 121/72, heart rate 90, respiratory rate 20, temperature 97.6 on (b)(6) 2017 prior to discharge, the patients¿ vital signs were stable, no apparent discomfort and patient denied any shortness of breath (sob) patient was discharged to home with continued monitoring of ccpd therapy as well as the assessment of addition of mid-day exchange for improvement of creatinine clearance, and new prescription for home ccpd regime and dialysate strength.

• 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: 6450287
• MDR Text Key: 71409645
• Report Number: 2937457-2017-00223
• 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: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2011
• 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: DEFLEX PD FLUID; LIBERTY CYCLER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR