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

Model Number 180111

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

Patient Problems Pain (1994); No Information (3190)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review: there is a temporal relationship between pd therapy and the patient report of the cycler filling her with air resulting in pain.However, there is no documentation to show a causal relationship between the adverse event and use of the liberty select cycler.There is no report of a device malfunction, deficiency or defect reported for this event.The air detected in cassette message will appear if any air over the set volume limits is breached.There are several causes why a patient would have air infusion during peritoneal dialysis including technique-related pneumoperitoneum and visceral perforation.The pd catheter provides a portal of entry for the air into the peritoneal cavity.The liberty select cycler performed as designed to alert the patient of an issue.Additionally, there is no confirmation that any air was infused into the patient or that any medical intervention was received when the patient went to the hospital.There is no confirmation that the patient was hospitalized.Based on the limited information and no report of a device malfunction or deficiency, the liberty select cycler can be excluded as the cause of the patient¿s adverse event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A patient on peritoneal dialysis (pd) contacted fresenius technical support to request a replacement liberty select cycler.The patient stated they had to go to the hospital for pain (unspecified) and believes the cycler was filling them with air.The patient stated they has received an air detected in cassette message but did not see any leak.The technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.A replacement cycler was issued to the patient.Additional information was requested, however to date has not been provided.

Manufacturer Narrative

Additional information: d10, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.There were no visual indications of dried fluid encountered within the cassette compartment.There were visual indication of particulates around the catch post area and within cassette compartment.There were no burrs or sharp edges in the cassette area that may have punctured a cassette membrane.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.The cycler passed a teach pumps test.The cycler failed a pump integrity test due to weak pump a and b motors.There were visual indications of dried fluid found in between of the pump assembly and display assembly during internal inspection.There were visual indications of dried fluid within the recess of the bottom cover adjacent to the pump during internal inspection.A review of the device manufacturing records was conducted by the manufacturer.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler tested negative for glucose.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.

• Brand Name: UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 9526707
• MDR Text Key: 173280600
• Report Number: 2937457-2019-03654
• 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: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180111
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Device Age: MO
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention