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

Model Number LIBERTY SELECT CYCLER

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

Patient Problems Headache (1880); Myocardial Infarction (1969); Nausea (1970); Vomiting (2144)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Temporal relationship exists between ccpd therapy utilizing the liberty select cycler and the adverse event(s) of headache, nausea, vomiting and probable nstemi.The etiology of the headache, nausea, vomiting and probable nstemi are unknown.However, it is known that patients with renal failure commonly suffer from gastrointestinal complication¿s (1), and patients with chronic kidney disease (ckd) are likely to have chronically elevated troponin levels (2,3).Therefore based on the information available causality cannot be fully determined.There is no documentation or indication a fresenius device(s) caused or contributed to the event(s).Additionally, there is no allegation of the machine malfunctioning or the machine not performing as expected.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 patient was went to the er and was admitted to the hospital for a cardiac assessment.Additional information was solicited and received.On (b)(6) 2018, this female patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) presented to the emergency room (er) with complaints of headache, nausea and vomiting for 2 days, and was subsequently admitted for further cardiac evaluation.During a follow-up call for related file, the peritoneal dialysis registered nurse (pdrn) reported the patient called the clinic on (b)(6) 2018 to report feeling ¿poorly¿ and nauseous after pd therapy.According to the discharge summary received on (b)(6) 2018, a computed tomography (ct) scan of the head/brain was performed and exhibited no acute findings.Laboratory studies revealed an elevated troponin of 1.18, at which point the patient was diagnosed with a probable non-st elevation myocardial infarction (nstemi).The patient underwent a cardiac catheterization on (b)(6) 2018, and while the exact results are unknown, it is known that no intervention was performed.Additional information regarding the hospitalization is unknown.However, the records indicate the patient signed out of the hospital against medical advice (ama) on (b)(6) 2018 and was subsequently hospitalized three days later which is captured on related customer experience.

• Brand Name: LIBERTY SELECT CYCLER ASSY(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: 7456278
• MDR Text Key: 106383194
• Report Number: 2937457-2018-01143
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171652
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY SELECT CYCLER
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2009
• 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