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 Problems Chest Pain (1776); Abdominal Distention (2601)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Clinical review: based on the information available, there is no evidence or indication a fresenius product(s) and/or device(s) caused or contributed to a serious adverse patient event.Additionally, there is no allegation of a machine malfunction or of the machine failing to perform as expected in relation to the event.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 re-evaluated accordingly.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A peritoneal dialysis nurse (pdrn) for a peritoneal dialysis (pd) patient on continuous cycling peritoneal dialysis (ccpd) for renal replacement therapy (rrt) contacted technical support for assistance and during the call the pdrn reported the patient had chest pain and abdominal pressure after disconnecting from the fresenius liberty select cycler.Upon follow up, the pdrn stated the patient was hospitalized from (b)(6) 2018 with symptoms of chest pain.The patient was found to have blocks in their heart and stents were placed during hospitalization.The pdrn confirmed that the patient did not experience fluid overload and was stated that the cause of abdominal pressure was unknown.The patient recovered and was discharged from the hospital, and continues pd therapy without issue.It is unknown if pd therapy was continued in the hospital or if any fresenius device(s) or product(s) were utilized during hospitalization.Additional details surrounding the patient¿s hospital course and condition were requested, however, not provided.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed on the cycler and showed that the front panel bezel gasket was drooping approximately 0.5 inches over the center of the front panel overlay; this did not obstruct the view or the functionality of the touch screen.There was no evidence of dried fluid present within the cassette compartment and there were no burrs or sharp edges in the cassette area that could have punctured the cassette membrane.A ¿go/no go gauge¿ check was performed and passed with no issued noted.An as-received simulated treatment was performed on the cycler and completed without failure.The weighed fill volumes were within tolerance and there were no fluid leaks in the test cassette.They cycler underwent and passed a system air leak test and a valve actuation test.The load cell verification was found to be within tolerance.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler tested negative for glucose.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.A review of the device manufacturing records was conducted by the manufacturer and found no deviations or non-conformances.A device history record review was performed and verified that the results of the in-progress and final quality control testing met all requirements.Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the 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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8190326
• MDR Text Key: 131181480
• Report Number: 2937457-2018-03722
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Device Age: MO
• Date Manufacturer Received: 02/01/2019
• 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; Life Threatening; Required Intervention