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 Bacterial Infection (1735); Dyspnea (1816); Fever (1858); Myocardial Infarction (1969); Nausea (1970); Electrolyte Imbalance (2196)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Additional information: microbiology: ((b)(6) 2017): blood culture- growth clostridium perfringens and staphylococcus epidermis from anaerobic bottle, staphylococcus capitas from aerobic bottle; pd effluent culture- no growth after 3 days; gram stain: few wbc (14), red blood cell (rbc) 19.On ((b)(6) 2017): wound culture (left foot)-heavy streptococcus group g; heavy growth staphylococcus aureus.On ((b)(6) 2017): blood culture- no growth after 5 days.While a possible temporal relationship exists between ccpd therapy with the liberty cycler and the pt¿s chest pain with associated symptoms of nausea and shortness of breath (dyspnea) requiring subsequent hospitalization; there is no documentation to support a causal relationship.The pt¿s chest pain was attributed to myocardial infarction from significant cad (with evidence of 90 % ostial in-stent restenosis) warranting pci and drug eluting stent placement in native coronary artery.Moreover, the pt.Had several pre-existing comorbid conditions which increased risk for myocardial infarction; most notably cad, type 2 diabetes mellitus, cardiomyopathy and hyperlipidemia.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

During routine follow up on an unrelated customer experience, the peritoneal dialysis nurse reported that the peritoneal dialysis patient was hospitalized for chest pain.Additional information was solicited and received.On (b)(6) 2018, this patient (pt.) on continuous cycling peritoneal dialysis (ccpd) presented to the emergency room (er) with complaints of chest pain with associated symptoms of nausea and shortness of breath (dyspnea) and was admitted into the hospital.The pt¿s past medical history significant for coronary artery disease(cad) with previous coronary artery stenting; type 2 diabetes mellitus, peripheral artery disease (pad), heart failure, anemia, cardiomyopathy, hyperlipidemia and concomitant left foot diabetic ulcer.During hospital; course, it was determined the pt.Suffered a non-st elevated myocardial infarction (nstemi) which required percutaneous coronary intervention (pci) and drug eluting stent placement (date unknown) due to significant cad.Incidentally, the pt.Was also hyponatremic (sodium 132) and hyperglycemic (blood glucose 311) on hospital admission however, the pt.¿s sodium level was within normal range on (b)(6) 2017.The pt¿s blood glucose remained elevated during hospital course.Notably, the pt¿s hemoglobin a1c was elevated (9.6) on hospital admission which is an indicator of poor overall glycemic control of the pt¿s type 2 diabetes mellitus.Reportedly, the pt.Was continued on pd therapy during hospitalization (product and treatment details are unknown).Additionally, it is noted the pt.Had a fever [unknown date and temperature (temp.)].Blood cultures results revealed the pt.Was bacteremic with growth of the organisms clostridium perfringens, staphylococcus epidermis and staphylococcus capitas.Furthermore, the pt¿s wound culture (left foot on (b)(6) 2017) revealed heavy growth of the organisms streptococcus group g and staphylococcus aureus.Subsequently (on (b)(6) 2017), the pt.Underwent a computerized tomography (ct) scan of the face which indicated the pt.Had significant periodontal infection.Notably, there was no evidence the pt.Had peritonitis as pd effluent cultures remained negative for bacterial growth and had very few wbc (count 14).On (b)(6) 2018, the pt¿s wbc was elevated (result 11.4).Vital signs recorded include blood pressure (bp) 162/91, pulse (p) 93, temp.97.5 f (afebrile), respiratory rate (rr) 18, oxygen saturation 96% and (b)(6) and physical exam was unremarkable.Moreover, on (b)(6) 2018, the pt.Had a peripherally inserted central catheter (picc) line placed and was deemed stable for discharge home (with home care services) continuing pd therapy on a 2-week course of iv zosyn (antibiotic).During a follow up call with the pt¿s pd nurse (on (b)(6) 2018), it was reported the pt.Has since fully recovered and it was confirmed the pt¿s hospitalization was not related to the liberty cycler.

• 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: 7358680
• MDR Text Key: 103091128
• Report Number: 2937457-2018-00838
• 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,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• 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?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/11/2010
• 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
• Treatment: ALLERGIES; AMLODIPINE; ASPIRIN; ATORVASTATIN; CALCIUM CARBONATE; CARVEDILOL; CLONIDINE; CLOPIDOGREL; DOCUSATE SODIUM; FUROSEMIDE; GLIPIZIDE; HYDROCODONE-ACETAMINOPHEN (AS NEEDED),; INSULIN; LOSARTAN; MINOXIDIL; NITROGLYCERIN; PD SOLUTION (1.5% AND 2.5% STRENGTH),; VICTOZA
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR