MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Model Number LIBERTY CYCLER SET,

Device Problem Fluid/Blood Leak (1250)

Patient Problem Inflammation (1932)

Event Date 02/21/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

Peritoneal dialysis patient reported observing a fluid leak on the floor and in the liberty select cassette compartment.The cycler did alarm but the patient could not confirm the type of alarm that was encountered.Follow up with the patients peritoneal dialysis nurse indicates that the patient did have abdominal inflammation but was not diagnosed with any infection.The patient was prescribed prophylactic antibiotics, ip vancomycin 3 times a week and oral keflex.The liberty cassette was discarded.

Manufacturer Narrative

Correction: weight.

Event Description

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Manufacturer Narrative

The alleged event is not confirmed.The device was not returned to the manufacturing plant for investigation.All companion samples have been sold and distributed.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

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• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: 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: 7333772
• MDR Text Key: 102213332
• Report Number: 8030665-2018-00365
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00840861100750
• UDI-Public: 00840861100750
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER SET,
• Device Catalogue Number: 050-87216
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIBERTY SELECT; PD SOLUTION; LIBERTY SELECT; PD SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Weight: 107