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

Model Number 180343

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

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical investigation: based on the available information, the patient¿s liberty select cycler is disassociated from the event(s).There is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event related to a fresenius device(s) or product(s) occurred warranting further investigation.

Event Description

A patient contact reported that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized (date not provided).The reason for hospitalization is unknown.Subsequent attempts to obtain additional information (e.G., discharge summary) have thus far proven unsuccessful.

Event Description

A patient contact reported that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized (date not provided).The reason for hospitalization is unknown.Subsequent attempts to obtain additional information (e.G., discharge summary) have thus far proven unsuccessful.

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.There were visual indications of dried fluid within the cassette compartment on the top cover.There was no visual indication of particulates found within the cassette compartment.There were no burrs or sharp edges in cassette area that may have punctured a cassette membrane.The as received simulated treatment of a total volume of 18500ml was performed and completed without any failures or problems.During the treatment, the amount of fluid in the pseudo-patient bag after each fill was weighed and recorded, and the weighed fill values in each cycle was compared with the treatment's programmed fill setting.The cycler weighed fill volume values were within tolerance.The cycler underwent and passed a system air leak test, valve actuation test, and the check functionality of the patient sensors.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 underneath the pump assembly on the bottom cover and under the front panel assembly.The cause of the dried fluid could not be determined.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: LIBERTY SELECT CYCLER ASSY(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: 11312051
• MDR Text Key: 231315568
• Report Number: 2937457-2021-00228
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 180343
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Device Age: MO
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET ; LIBERTY CYCLER SET ; DELFLEX PD FLUID; LIBERTY CYCLER SET
• Patient Outcome(s): Hospitalization