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

Catalog 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	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.
Event or Problem Description
It was reported that a peritoneal dialysis patient identified a fluid leak coincident with peritoneal dialysis therapy.Prior to the event, the patient received a drain complications alarm during drain two of their therapy.Following the alarm, the patient contacted a technical support representative for assistance.During troubleshooting, it was verified that the connections were tight and the clamps were open.During the call the patient noted that last night they were unable to complete treatment due to having a fluid leak from the stay safe connector.The cause of the leak was unknown.The technical support representative advised the patient to discontinue use of the cycler and to notify their peritoneal dialysis registered nurse of the event.The patient reverted to manual supplies to complete their treatment.Follow up with the patient¿s peritoneal dialysis registered nurse verified that there was no patient injury or medical intervention required as a result of the reported leak.Per the clinic¿s procedure the patient was prescribed prophylactic intraperitoneal (ip) antibiotic vancomycin 1g, one dosage following the event.The cause for the leak was noted to be the patent not tightening the connection.The cassette used at the time of the incident was discarded.The patient has been able to continue with peritoneal dialysis therapy without complications.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, 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.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 7335570
• Report Number: 8030665-2018-00370
• Device Sequence Number: 13646784
• Product Code: FKX
• UDI-Device Identifier: 00840861101993
• UDI-Public: 00840861101993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2018

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: 09/30/2018
• Device Catalogue Number: 050-87222
• Device Lot Number: 17LR08001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 03/13/2018
• Supplement Report FDA Received Date: 04/12/2018
• 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
• Patient Age: 67 YR
• Patient Weight: 57