MAUDE Adverse Event Report: CONCORD MANUFACTURING UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED); SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY CYCLER

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

Patient Problems Pneumonia (2011); Sepsis (2067)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: there is no documentation to show a causal relationship between the patient¿s events of sepsis, cough, tachypnea and leukocytosis with subsequent hospitalization and diagnosis of community acquired pneumonia, hypokalemia and hyponatremia.There is a possible temporal relationship between the electrolyte imbalances and pd therapy on the liberty cycler, however, it is unknown if the imbalance started during pd on they cycler or during the hospitalization where the patient was not utilizing fresenius product.Hypokalemia is a frequent problem in peritoneal dialysis (pd) and found in (b)(4)% of pd patients (kim et al, 2007).It is likely that the sepsis was a result of the community acquired pneumonia, however, the patient was also found to have a positive urine culture.Based on available information the source of the sepsis is not confirmed.The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

The peritoneal dialysis patient contact stated that the patient had been in the hospital.Additional information was obtained from the patient¿s peritoneal dialysis registered nurse (pdrn) on (b)(6) 2018 and through medical records received (b)(6) 2018.The patient went to the emergency room (er) on (b)(6) 2018 with a cough that started two weeks prior.The cough had been constant, productive of yellow sputum, partially relieved with breathing treatments and with no exacerbating factors.The patient had been seen at an urgent care while out of state 1-2 weeks before and was prescribed/treated with mucinex and prednisone (route, dose, strength, frequency and duration unknown).The patient¿s symptoms did not relieve and that is the reason she presented to the er.The patient was admitted due to being septic with tachypnea and leukocytosis (wbc 21.3 on (b)(6) 2018).Blood and pd effluent cultures were documented to show no growth, however, a urine culture was positive for mixed gram positive flora with >=100,000 cfu/ml.A chest x-ray revealed left lower lobe consolidation favoring pneumonia and the patient was started on empiric antibiotics (type, route, dose, strength, frequency and duration unknown).The patient also appeared wheezy on initial presentation and was started on steroids and small volume nebulizer (type, route, dose, strength, frequency and duration unknown) for mild chronic obstructive pulmonary disease (copd) exacerbation.The patient¿s condition improved overall and she was transitioned to oral antibiotics on discharge (azithromycin 500mg tablet once daily for 5 days).During hospitalization, the patient was diagnosed with hyponatremia (128) and hypokalemia (3.1) and unknown if patient received treatment.The patient was also found to have an elevated troponin level of 0.11 and due to some premature ventricular contractions (pvc), bigeminy and short runs of ventricular tachycardia, an echocardiogram was performed.The echo revealed multiple abnormalities including an ejection fraction of 20-25% diastolic dysfunction, aneurysmal left ventricular apex, and valvulopathy.Per cardiology consult, no further workup was warranted as the patient had previously seen a cardiologist.The patient continued with pd therapy during the hospitalization with use of non-fresenius product.The patient was discharged (b)(6) 2018 in stable condition with only a cough remaining.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• 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: 7567248
• MDR Text Key: 110028725
• Report Number: 2937457-2018-01554
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2014
• 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: 86 YR