MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY PDX, INTEGRATED SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number	050-87222
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
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
A peritoneal dialysis (pd) patient reported to fresenius customer service that their cassette leaked during an unknown phase of pd treatment.Upon follow up, the pd registered nurse (pdrn) confirmed the reported event.The pdrn reported that treatment was completed with continuous ambulatory peritoneal dialysis (capd).The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The patient was treated with one dose of prophylactic antibiotics 2g ceftazidime and 1.5g vancomycin via intraperitoneal administration.The cassette used by the patient is available.A sample return kit was shipped to the customer so they can return the reported cassette to the manufacturer.The reported cycler was replaced after the second occurrence and patient has been able to complete treatment without any issues.That cycler has been returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: the tracking information for the shipping label provided to the customer indicates that the sample was never returned.A physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Additional Manufacturer Narrative
Plant investigation: the device was returned to the manufacturer and a physical evaluation was performed.Visual inspections and functional tests were performed on the returned sample.There were no issues identiifed.The sample was found acceptable.Based on the sample evaluation, the event was not confirmed and the cause could not be establised.The returned sample was scrapped after evaluation.
Additional Manufacturer Narrative
H3 plant investigation: sample was returned and will undergo a physical evaluation.Details of the evaluation will be submitted upon completion.

• Brand Name: LIBERTY PDX, INTEGRATED SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 9335026
• Report Number: 8030665-2019-01746
• Device Sequence Number: 1724559
• Product Code: FKX
• UDI-Device Identifier: 00840861101993
• UDI-Public: 00840861101993
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K141145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/18/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 050-87222
• Device Catalogue Number: 050-87222
• Device Lot Number: 19HR08147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Device Age: MO
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/21/2019; 02/12/2020; 02/14/2020
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 11/22/2019; 02/14/2020; 02/18/2020
• 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 PDX CYCLER; DELFLEX PD FLUID; LIBERTY PDX CYCLER
• Patient Age: 65 YR
• Patient Weight: 83