MAUDE Adverse Event Report: RENOSA MANUFACTURING LIBERTY CYCLER SET, DUAL PT CONNECT

Catalog Number 050-87212

Device Problems Fluid/Blood Leak (1250); Difficult to Insert (1316)

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

Event Date 08/13/2014

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) pt's nurse reported that the pt had difficulty inserting the cassette into the cycler.He was able to get the cassette attached enough to close the door.He proceeded with treatment.When he completed treatment he discovered fluid leaking from the cassette.The set was discarded.During follow up, the pt's pd nurse reported that his effluent has remained clear.He has not had any signs of infection.He was not treated with any antibiotic.No adverse event reported at this time.

Manufacturer Narrative

The device was not returned to the mfr for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the mfr.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within speciations.

• Brand Name: LIBERTY CYCLER SET, DUAL PT CONNECT
• Manufacturer (Section D): RENOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynos. s.a. de c.v.; mike allen 1331 parque industrial; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn ; 920 winter st; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4109582
• MDR Text Key: 20659265
• Report Number: 8030665-2014-00728
• 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,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2017
• Device Catalogue Number: 050-87212
• Device Lot Number: 14CR08020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Patient Age: 72 YR
• Patient Weight: 67