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

Catalog Number RTLR180343

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

Patient Problem No Information (3190)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.The file was assessed to determine whether a clinical investigation is warranted.On (b)(6) 2019, fresenius became aware a patient with renal failure (rf) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy was hospitalized (specifics and dates not provided).Subsequent attempts to obtain additional information have thus far proven unsuccessful.Based on the information available, the liberty select cycler and fmc cassette are disassociated from the event(s), as there is no allegation or objective evidence indicating a product deficiency or malfunction caused or contributed to the patient¿s hospitalization.Therefore, the completion of a clinical investigation is not warranted at this time.Should additional information become available the need for a clinical investigation will be reassessed accordingly.

Event Description

A hospital nurse called in to report a fluid leak during an unknown patient's peritoneal dialysis (pd) treatment on the liberty select cycler.The fluid leak is captured and investigated in a separate record.Patient information and reason for patient's hospitalization was not reported.Multiple attempts were made to acquire additional information, however, to this date no response has been received.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler with no physical damage noted.Upon opening the cassette compartment, there were visual indications of dried fluid within the cassette compartment.There were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.An accelerated stress test (ast) was performed and passed without any fluid leaks.A two hour and fifteen minute simulated treatment with 8500ml was performed and completed without failures.The cycler underwent and passed a valve actuation test and system air leak test.The cycler tested positive for glucose.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection identified evidence of dried fluid beneath the mushroom heads of pump a and b and within the recess of the bottom cover adjacent to the pump.The cause of the dried fluid could not be determined.There were no other visual discrepancies observed during internal inspection.A review of the device manufacturing records was conducted by the manufacturer.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.

Event Description

A hospital nurse called in to report a fluid leak during an unknown patient's peritoneal dialysis (pd) treatment on the liberty select cycler.The fluid leak is captured and investigated in a separate record.Patient information and reason for patient's hospitalization was not reported.Multiple attempts were made to acquire additional information, however, to this date no response has been received.The cycler was returned to the manufacturer for physical evaluation.

• Brand Name: LIBERTY SELECT CYCLER ASSY(NON-VALUATED)
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8940381
• MDR Text Key: 155961669
• Report Number: 2937457-2019-02758
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861102068
• UDI-Public: 00840861102068
• Combination Product (y/n): N
• PMA/PMN Number: K181108
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Device Age: MO
• Date Manufacturer Received: 09/06/2019
• 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