MAUDE Adverse Event Report: CONCORD MANUFACTURING LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problems Device Issue (2379); Device Handling Problem (3265)

Patient Problem Peritonitis (2252)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental mdr will be submitted upon device evaluation.

Event Description

A peritoneal dialysis patient's nurse reported the patient often had to complete a manual drain following use of the cycler due to the patient having residual effluent.The disconnecting from the cycler and connecting to manuals led to a breach in technique that resulted in peritonitis.The cycler was replaced.During follow up the patient's nurse reported the patient had an event of peritonitis during (b)(6) 2017 (specific date unknown).The patient's effluent grew staph epidermidis and white blood cell count was 12580 (units unspecified).The patient was treated with vancomycin and recovered.The patient was not hospitalized for the event.

Event Description

Clinical investigation: a peritoneal dialysis registered nurse (pdrn reported the liberty cycler is not draining the patient completely which causes the patient to have to do manuals to drain the remaining fluid.Typically, the patient drains 500-800 ml during manual drain when their fill volume is 2,000ml.The pdrn requested a replacement cycler.The pdrn stated that the patient had peritonitis from having to disconnect from the cycler and connect to do frequent manual exchanges.The patient culture was positive for staphylococcus epidermidis with a white blood cell (wbc) count of 12580 (unspecified units).The patient was prescribed/treated with vancomycin (route, dose, strength, frequency and duration unknown) and recovered.The patient did not require hospitalization.The patient received a new cycler and has been completing pd therapy without issues.There is no documentation to show a causal relationship between the patient event of peritonitis and the liberty cycler or cycler set.There is however, a temporal relationship between the peritonitis and the patient disconnecting from the cycler and reconnecting to do manual exchanges due to incomplete draining.This is the possible causal event of the peritonitis.The cause of the patient not draining is unknown as there are no previous reported issues with the liberty cycler.

Manufacturer Narrative

Additional information: clinical investigation.Device evaluation: the actual device was returned to the manufacturer for physical evaluation.A visual inspection of the returned cycler exterior showed that the front panel bezel gasket was drooping approximately.5 inches over the center of the front panel overlay.This does not obstruct the view or the functionality of the touch screen.There were no indications of dried fluid inside the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.A simulated treatment was performed and completed without failures.During the treatment, a ¿drain complication encountered¿ support warning occurred, as expected, when the patient line was clamped during a drain phase.There were no fluid leaks in the test cassette during the treatment test.The cycler underwent and passed the system air leak test and valve actuation test.There were no discrepancies encountered in the internal inspection of the cycler.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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7232878
• MDR Text Key: 98732679
• Report Number: 2937457-2018-00324
• 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: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Device Age: MO
• Date Manufacturer Received: 02/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER SET; PD FLUID
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR