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 Problems Uremia (2188); Peritonitis (2252)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship between the patient¿s hospitalization for metabolic encephalopathy due to uremia and peritonitis and the liberty select cycler/liberty cycler set exists.However, there is no objective evidence which indicates the peritonitis or uremia was caused by a liberty select cycler/liberty cycler set malfunction or product deficiency.The patient¿s uremia is most likely associated with a short-prescribed dwell time, as reported by the pd nurse, the patient¿s pd prescription was adjusted and the patient has since recovered.Peritonitis is a well-documented complication known to occur in pd therapy.At this time, it is unknown what exactly caused the patient¿s peritonitis event.Should additional information become available this clinical investigation will be updated accordingly.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A peritoneal dialysis registered nurse (pdrn) contacted fresenius technical support to report the liberty select cycler is draining slowly during drain 1.The pdrn stated the patient was submitted to the hospital this morning.Upon follow up, pdrn confirmed that the patient was hospitalized from (b)(6) with a diagnosis of toxic metabolic encephalopathy believed to be due to uremia and peritonitis.The pdrn stated that the patient was uremic and believed it to be due to the patient not receiving sufficient dialysis as he had shorter dwell time.The patient is however complaint to dialysis and did not miss his treatments.Additionally, the patient had peritonitis with elevated white blood cell of 25000 though the pd fluid cultures and blood cultures were negative for growth.The patient was placed on vancomycin and ciprofloxacin.Pd prescription was changed in the hospital from treatment based to cycle based with longer dwells.The patient's number of exchanges and fill volume remained the same at 4 exchanges with 2500ml, last fill volume of 2000ml and a day time exchange with 2000ml.The pdrn attributed the events to the patient having shorter dwell time.The patient has continued pd therapy without issues since discharge on longer dwells and has recovered from the aforementioned events.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.A simulated therapy was initiated and completed on the cycler without complication.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.A patient sensor calibration test was also performed and the cycler was found to be within tolerance.Load cell verification testing was performed with no issues noted.A review of the device manufacturing records was conducted by the manufacturer.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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8102846
• MDR Text Key: 128310245
• Report Number: 2937457-2018-03451
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Device Age: MO
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/26/2018
• Supplement Dates Manufacturer Received: 12/14/2018
• Supplement Dates FDA Received: 01/03/2019
• 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
• Patient Age: 69 YR