MAUDE Adverse Event Report: REYNOSA MANUFACTURING LIBERTY CYCLER SET, SINGLE PATIENT CONN

Catalog Number 050-87215

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250)

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

Event Date 01/11/2014

Event Type  malfunction  

Event Description

The peritoneal dialysis patient's husband called technical support and reported that the patient's tubing set had detached from her catheter during treatment, so the work up during the night and noticed the bed was soaked.The patient reported that part of the blue pin connector was found lying on the floor.The patient received prophylactic antibiotics, her effluent remained clear, and she felt fine.

Manufacturer Narrative

The actual device was not returned to the mfr for physical eval; however, a companion sample from the same lot was returned for investigation and no defects were noted.In addition, an investigation of the device mfg records was conducted by the mfr.There were no deviations or non-conformances during the mfg process.In addition, the batch record review confirmed the labeling, material, and process controls were within spec.

• Brand Name: LIBERTY CYCLER SET, SINGLE PATIENT CONN
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; parque ind. reynosa sur brecha e-99; apartado postal #326; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: tanya taft, rn ; 920 winter street; waltham, MA 02451 ; 7816999751
• MDR Report Key: 3755477
• MDR Text Key: 4551471
• Report Number: 8030665-2014-00160
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K403363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Type of Report: Initial
• Report Date: 01/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2016
• Device Catalogue Number: 050-87215
• Device Lot Number: 13JR08110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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