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

Catalog Number 050-87216

Device Problem Leak/Splash (1354)

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

Event Date 01/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A supplemental report will be submitted upon completion of plant¿s investigation.

Event Description

A peritoneal dialysis (pd) patient called technical services and stated that she encountered air detected in cassette warning during fill 5/5.During treatment end process patient removed the cassette from liberty cycler and fluid had leaked out of the cassette door area.Patient stated her nurse had advised her to discontinue use of the cycler and continue treatment with continuous ambulatory peritoneal dialysis (capd).During follow-up with the patient she confirmed her effluent had remained clear after the reported event.The set may be available for evaluation.There were no adverse events experienced by the patient as a result of this incident.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.The entire lot has been sold and distributed.Batch record for the lot identified was reviewed and confirmed there were no non-conformances and/or any associated rework during the manufacturing process.In addition, the device record review confirmed result of in-progress, and final qc testing were found with acceptable results.

• 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6298926
• MDR Text Key: 66433564
• Report Number: 8030665-2017-00041
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 050-87216
• Device Lot Number: 16LR08019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LIBERTY CYCLER; PD FLUID
• Patient Age: 70 YR
• Patient Weight: 81