MAUDE Adverse Event Report: REYNOSA MANUFACTURING LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

Catalog Number 050-87216

Device Problem Use of Device Problem (1670)

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

Event Date 01/29/2014

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) patient reported tearing his patient line.He stepped too far from the cycler while sleepy and the extension line broke.His catheter was not affected he went to the hospital to get checked.He did not experience any infections and did not require any antibiotics.A nurse at the hospital showed him the proper way to disconnect and helped him finish his treatment for the night.There was no injury associated with this event.The set was discarded and will not be available for investigation.

Manufacturer Narrative

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

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen 1331 parque industrial; reynosa ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 3826203
• MDR Text Key: 20783783
• Report Number: 8030665-2014-00174
• Device Sequence Number: 1
• Product Code: FKX
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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