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 Pneumonia (2011)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.A device history review could not be performed since the serial number of the device is unknown.

Event Description

During follow up on an unrelated customer experience it was reported that the peritoneal dialysis patient was treated for pneumonia on an unknown date in 2018.It is unknown if there was any relationship between the patients peritoneal dialysis treatments or pneumonia.Additional information was solicited.

Manufacturer Narrative

Lack of sufficient information regarding the patient¿s hospitalization for pneumonia and sepsis precludes a meaningful assessment of this case.At this time, the etiology for the patient¿s pneumonia and sepsis cannot be determined.However, there have been no reported allegations against the liberty cycler as a possible causal factor.Further information has been solicited.

Event Description

".".

• 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: 7397301
• MDR Text Key: 104405139
• Report Number: 2937457-2018-00957
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• 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
• Device Age: MO
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR