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 Problem Chest Pain (1776)

Event Date 12/09/2017

Event Type  Injury  

Manufacturer Narrative

It cannot be determined if the liberty cycler may have caused or contributed to the patient¿s adverse event of chest pain that required hospitalization.It is unknown if the patient was performing ccpd treatment with the liberty cycler at the time the chest pain occurred.However, there are no reported allegations which implicates the liberty cycler may have been related the patient¿s adverse event.The patient¿s previous history of chronic chest pain (for which the patient is known to self-administer nitroglycerin regularly) is a very likely factor in this case.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 for an unrelated customer experience, it was reported by the peritoneal dialysis (pd) nurse that this patient (pt.) on continuous cycling peritoneal dialysis (ccpd) was hospitalized on or about (b)(6) 2017.Details of events leading up to and surrounding hospital course are unknown at this time.It is unknown when in relation to ccpd treatment the pt.Experienced chest pains although, per the pt¿s pd nurse, it was unlikely the pt.Was performing ccpd treatment when it occurred.The pt.Is reported to have prior history of chronic chest pain for which the pt.Self-administers nitroglycerin on a regular basis.The pd nurse also reported the pt.Is generally non-complaint.Additional information was solicited.

Manufacturer Narrative

Based on the lack of information in the complaint file, it can not be determined if the liberty cycler may have caused or contributed to the patient¿s adverse event of chest pain that required hospitalization (details unknown).It is unknown if the patient was performing ccpd treatment with the liberty cycler at the time the chest pain occurred.However, there are no reported allegations contained within the complaint file which implicates the liberty cycler may have been related the patient¿s adverse event.The etiology for the patient¿s chest pain cannot be determined.The patient¿s previous history of chronic chest pain (for which the patient is known to self-administer nitroglycerin regularly) as well as anemia of chronic kidney disease and hypertension are possible confounding factors in this case.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

Information in the complaint file and 7 pages of medical records received on (6/feb/2018) were reviewed.During follow up for a separate event, it was reported by the peritoneal dialysis (pd) nurse that this patient (pt.) with end stage renal disease (esrd) on continuous cycling peritoneal dialysis (ccpd) was hospitalized on or about (b)(6) 2017 for chest pain.Details of events leading up to and surrounding hospital course are unknown at this time.It is unknown when in relation to ccpd treatment the pt.Experienced chest pains although.However, the pt¿s pd nurse stated it was unlikely the pt.Was performing ccpd treatment when the chest pains occurred.The pt.Is reported to have prior history of chronic chest pain for which the pt.Self-administers nitroglycerin on a regular basis.The pd nurse also reported the pt.Is generally non-compliant.

• 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
• MDR Report Key: 7163472
• MDR Text Key: 96332619
• Report Number: 2937457-2018-00045
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100972
• UDI-Public: 00840861100972
• Combination Product (y/n): N
• PMA/PMN Number: K123630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Age: MO
• Initial Date Manufacturer Received: 12/09/2017
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION; LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR