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

Catalog Number RTLR180343

Device Problem Overfill (2404)

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

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) patient contact stated the patient was experiencing drain complication encountered messages during treatment.Upon review of the patient¿s treatment records, it was discovered that the patient drained 4381 ml during drain 4 of 4 of treatment.This drain is 183% of the patient¿s largest fill volume of 2397 ml.A new cycler was issued to the patient and the patient contact was advised to follow-up with the patient's peritoneal dialysis registered nurse (pdrn).Upon follow-up, pdrn stated they were not aware of the reported event.However, the pdrn stated that they have recently seen the patient and could confirm that the patient did not experience any symptoms, injury, adverse event, or require medical intervention as a result of the reported event.Additional information was requested but to date, has not been provided.

Manufacturer Narrative

Plant investigation: the actual device was returned to the manufacturer for physical evaluation.An external visual inspection was performed with no physical damage noted.There were no indications of dried fluid inside the cassette compartment.No burrs or sharp edges in cassette area that may have punctured a cassette membrane.A simulated therapy was initiated and completed on the cycler without complication.The weighed fill volumes were found to be within tolerance.The cycler underwent system air leak and valve actuation testing and was found to meet product specifications.Load cell verification testing was performed with no issues noted.There was dried fluid within the recess of the bottom cover adjacent to the pump.The cause of the encountered dried fluid could not be determined.The mushroom head check passed.The cycler tested negative for glucose.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; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 8811623
• MDR Text Key: 151727440
• Report Number: 2937457-2019-02243
• 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
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2019
• Device Age: MO
• Date Manufacturer Received: 08/14/2019
• 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 Age: 70 YR
• Patient Weight: 95