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

Model Number	180237
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported by a patient contact that a peritoneal dialysis (pd) patient discovered a fluid leak on the inside of the cassette door of their cycler after ending their pd treatment.The patient received an air detected in cassette alarm, an m84 pump error alarm, and a make sure the heather bag (hb) is on the heater tray (ht) message during fill 6 of 6 of treatment.It is unknown at which point in therapy the leak may have begun.The cause of the leak is unknown.It was reported that the cycler made a loud popping noise throughout all phases of the patient's treatment.The patient was advised to discontinue the use of their cycler and a new cycler was issued to the patient.The patient reverted to an alternate form of treatment.The patient was also advised to follow up with their peritoneal dialysis nurse (pdrn).There was no adverse event, serious injury, nor medical intervention reported during the initial call.Additional information was requested, however, to date a response has not been received.The return of the cycler to the manufacturer was scheduled as well as the delivery of its replacement to the patient.The cycler set used by the patient was not returned to the manufacturer.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: the actual device was returned to the manufacturer.No physical damage was noted during an external visual inspection.A post- accelerated stress test (ast) simulated treatment was initiated and completed without failures,.The cycler underwent and passed a system air leak test, valve actuation test, teach pump test, and a patient sensor calibration check, and a safety clamp check.An investigation of the cycler mushroom heads verified that the surface conditions and alignments were within specification.An internal visual inspection of the cycler found the hp2 filter clogged with fluid.The hp2 filter was replaced.A review of the device manufacturing records was conducted and 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, no malfunctions were found that could have caused or contributed to the reported event.The cycler performed as designed and an associated cause could not be determined.The cycler was refurbished following the evaluation.

• Brand Name: LIBERTY PDX CYCLER ASSY (NON-VALUATED)
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): CONCORD MANUFACTURING; director, quality systems; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 10840316
• Report Number: 2937457-2020-02062
• Device Sequence Number: 14193099
• Product Code: FKX
• UDI-Device Identifier: 00840861100989
• UDI-Public: 00840861100989
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 180237
• Device Catalogue Number: RTLR180237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Device Age: MO
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; LIBERTY CYCLER SET