• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RENOSA MANUFACTURING LIBERTY CYCLER SET, DUAL PT CONNECT Back to Search Results
Catalog Number 050-87212
Device Problems Fluid Leak; Difficult to Insert
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIBERTY 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 Key4109582
Report Number8030665-2014-00728
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation
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 Received09/10/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/01/2017
Device Catalogue Number050-87212
Device LOT Number14CR08020
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/15/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/10/2014 Patient Sequence Number: 1
Treatment
LIBERTY CYCLER
-
-