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

Catalog Number RTLR180111

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

Patient Problem Uremia (2188)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship exists between ccpd therapy utilizing the liberty cycler and the event(s) of insufficient dialysis leading to uremia and pd catheter (not a fresenius product) evaluation, which warranted hospitalization.The pdrn¿s attributes the insufficient dialysis and uremia to liberty cycler issues.Based on the limited information available, the liberty cycler cannot be disassociated from the event.The liberty cycler manufacturer evaluation is pending at the time of this investigation.As such, the liberty cycler cannot be excluded from having a possible causal or contributory role in the event(s).Additional information was requested, however, to date not provided.

Event Description

A peritoneal dialysis patient reported being hospitalized on (b)(6) 2018.Upon follow-up, the pdrn stated that the patient visited the clinic as he had stopped draining on the 3rd cycler requiring manual exchanges.At the clinic, the catheter was power flushed with heparin when the solution went in fine but not coming out and the patient was advised to go to the hospital.The rn stated that the patient¿s labs were performed and their bun was between 48-88 indicating inadequate dialysis due to cycler issues.The patient is in the hospital where he was getting sufficient pd and his catheter was being evaluated and was scheduled for a reposition.Additionally, uremia is a part of disease complications.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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: 8145847
• MDR Text Key: 129762295
• Report Number: 2937457-2018-03619
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization; Required Intervention