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 Diarrhea (1811); Dyspnea (1816); Encephalopathy (1833); Fatigue (1849); Nausea (1970); Pleural Effusion (2010); Pneumonia (2011); Respiratory Distress (2045); Vomiting (2144); Weakness (2145); Electrolyte Imbalance (2196); Ulcer (2274); Respiratory Acidosis (2482); Confusion/ Disorientation (2553); Ascites (2596); No Code Available (3191)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A peritoneal dialysis (pd) patient's clinic registered nurse reported the pd patient had been hospitalized from (b)(6) 2017 due to dyspnea.Additional information and medical records were requested.

Manufacturer Narrative

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.

Event Description

A peritoneal dialysis (pd) patient's clinic registered nurse reported the pd patient had been hospitalized from (b)(6) 2017 to (b)(6) 2017 due to dyspnea.Additional information and medical records were requested.

Manufacturer Narrative

(b)(4).Used for pneumoperitoneum, productive cough with sputum production conclusion: there is a temporal association to previous hospitalization and on ccpd therapy with pleural effusion requiring readmission to the hospital 24 hours after previous hospital discharge.The patient was experiencing and presenting to hospital with intermittent tachypnea/ respiratory distress/dyspnea nausea vomiting and altered mental status.Additional admitting diagnoses are as follows: stage-v chronic kidney disease (poa), type 1 diabetes mellitus with ulcer present on admission (poa) , respiratory acidosis (poa) secondary to ensuing respiratory distress, pneumonia (poa) metabolic encephalopathy with hyponatremia possibly related to pd therapy.¿pneumoperitoneum and ascites may well be related to pd¿ therapy per physician documentation.Patient additionally had diagnostic imaging and evaluation which demonstrated focal pneumonia or aspiration, with associated small pleural effusions with associated compressive atelectasis.The patient requires follow up radiologic imaging requires follow up lab work cbc in 2 weeks.On (b)(6) 2017 the patient was discharged to rehabilitation facility post hospital discharge due to inability for family to care for patient adequately.Thorax ct scan without contrast to be performed in the future with reason for the examine identified as: follow up on pulmonary nodule and pneumonia (no date identified), discharge diet is restricted diabetic renal diet and low potassium diet, follow up appointment on (b)(6) 2017 with infectious disease consultant for follow up of positive fungal assay >500 and response to antifungal therapy with voriconazole.Due to multifactorial complexities of patient¿s high acuity past and present medical conditions that require intensive medical management and rapid evaluation, true causality cannot be determined.

Event Description

The file was reviewed by a post market surveillance clinician.A peritoneal dialysis registered nurse (pdrn) reported this pd patient with end stage renal disease (esrd) experienced dyspnea and was subsequently hospitalized on from (b)(6) 2017 for two episodes of nausea and vomiting.On (b)(6) 2017 the patient underwent chest x-ray imaging with findings of small pleural effusion present.During hospitalization the patient underwent and received medical, infectious disease (id) and nephrology management of her overall clinical status throughout her hospitalization.The patient was full code status on this admission and the patient required continuous supplemental oxygen 3 liters per minute via nasal cannula.Additional admitting diagnoses were stage-v chronic kidney disease, type 1 diabetes mellitus with ulcer, respiratory acidosis and pneumonia.The identified medical conditions and admission diagnosis was the patient initially presented with altered mental status.On presentation the patient was drowsy but arousable, and encephalopathy likely due to underlying conditions including clostridia difficile colitis, pneumonia and mild hyponatremia.Throughout the hospital course mental status continued to improve while treating underlying medical conditions at time of discharge she has returned to her baseline cognitive and mental status.The patient was persistent with leukocytosis throughout hospitalization stay with white blood count up to 23.6 on (b)(6) 2017, and was initially presumed secondary to health care associated pneumonia (hcap)/pneumonitis.The patient was with intermittent tachypnea/ respiratory distress/dyspnea, and on (b)(6) 2017 the chest computerized tomography (ct) findings were bilateral nodular opacities predominately in the upper lobes is concerning for multifocal pneumonia versus aspiration pneumonia, requiring infectious disease (id) consult to identify the appropriate antibiotic treatment plan, iv cefepime and clindamycin.A total of 3 doses were administered with an outpatient plan to follow up with a repeat chest ct scan in approximately 8 weeks to follow up on resolution of pneumonia, incidentally discovered pulmonary nodule , likely invasive aspergillosis.Additionally the patient had a positive fungal assay >500 and (pt.Is on chronic low dose prednisone and leflunomide for rheumatoid arthritis and the ct chest scan findings are concerning for invasive pulmonary aspergillosis.On (b)(6) 2017 the patient began having softer stools with reoccurrence on (b)(6) 2017 of stool culture again positive for c-difficle /north american pulsed-field gel electrophoresis type 1 (nap1) negative.On (b)(6) 2017 the patient started on oral vancomycin and leukocytosis began to resolve.On (b)(6) 2017 the patient¿s abdomen was reportedly non-tender with a treatment plan to continue oral vancomycin every 6 hours for a total treatment plan of 2 weeks duration and follow up complete blood count check concurrently with her pcp provider to ensure the resolution of leukocytosis.The patient required insertion of an iv line to deliver iv hydration throughout the hospital stay.On (b)(6) 2017 the patient started on voriconazole with a treatment plan to continue oral voriconazole maintenance for total of 8 weeks treatment course duration.The patient was discharged on (b)(6) 2017 in documented stable condition and the patient was to have her voriconazole serum level checked in 5 days with repeat chest ct scan in 8 weeks for follow up on response to antifungal therapy.

• 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: 6695829
• MDR Text Key: 79350514
• Report Number: 2937457-2017-00562
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• 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: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2017
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2010
• 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): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 93