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

Model Number 180343

Device Problem Overfill (2404)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

This is a report of a patient who experienced an increased intraperitoneal volume (iipv) event coincident with peritoneal dialysis (pd) therapy.The event was discovered while reviewing the patient¿s treatment records following a report of a patient having a scale reading error alarm.A review of the patient¿s treatment records identified that the patient drained 4003 ml during drain 1 of the treatment.This drain volume is 200% the patient's prescribed fill volume of 2000 ml.As a result of the iipv event, the technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse (pdrn) of the event.Upon follow up with the pdrn, it was confirmed that the patient did not experience any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The pdrn stated that the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, but did not know if the patient was able to complete the peritoneal dialysis treatment using continuous ambulatory peritoneal dialysis (capd).The pdrn did not have any additional information regarding the reported event.The pdrn did not know if the patient has received their new cycler or if the old cycler was returned to the manufacturer for physical evaluation.Additional information has been requested, however to date has not been received.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

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 was no evidence of dried fluid present within the cassette compartment.An (as-received) simulated treatment was performed and completed without failures.The cycler weighed fill volume values were within tolerance for a liberty cycler.There were no fluid leaks in the test cassette during the treatment test.The cycler underwent and passed a system air leak test and valve actuation test.The load cell verification was within tolerance.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.The cycler tested positive for glucose.The internal inspection of the cycler showed that there were indications of dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the encountered 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 found that the an m65 scale reading error warning occurred during refurb which was resolved by calibrating the load cell.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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8815685
• MDR Text Key: 151853241
• Report Number: 2937457-2019-02268
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/29/2020
• Device Age: MO
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/23/2019
• Supplement Dates Manufacturer Received: 12/05/2019; 02/19/2020
• Supplement Dates FDA Received: 12/11/2019; 02/24/2020
• 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 Age: 48 YR
• Patient Weight: 82