Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

ERIKA DE REYNOSA, S.A. DE C.V. LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 050-87216
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2024
Event Type  malfunction  
Event Description
A peritoneal dialysis (pd) patient contact reported a fluid leak was discovered inside of the cassette module during treatment.The cycler prompted with m31 air detected in cassette warning alarm during drain 2 of 4 of treatment.The back of the cassette was intact.The patient was connected during the incident.The patient knew how to perform manuals.The patient was advised to cancel the treatment and follow up with the peritoneal dialysis registered nurse (pdrn).Upon follow up, the pdrn confirmed the reported event.The patient stated the fluid leak occurred during tx complete - step 9 remove cassette of treatment after treatment was cancelled and as the cassette door was opened.The pdrn confirmed there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The pdrn stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated they completed treatment using manuals on the night of the reported event.The pdrn confirmed the cycler set (cassette) used was no longer available to be returned for investigation.
 
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A peritoneal dialysis (pd) patient contact reported a fluid leak was discovered inside of the cassette module during treatment.The cycler prompted with m31 air detected in cassette warning alarm during drain 2 of 4 of treatment.The back of the cassette was intact.The patient was connected during the incident.The patient knew how to perform manuals.The patient was advised to cancel the treatment and follow up with the peritoneal dialysis registered nurse (pdrn).Upon follow up, the pdrn confirmed the reported event.The patient stated the fluid leak occurred during tx complete - step 9 remove cassette of treatment after treatment was cancelled and as the cassette door was opened.The pdrn confirmed there were no symptoms, adverse events, or injuries requiring medical intervention required as a result of the reported event.The pdrn stated the patient is trained on performing stat drains, as well as manual peritoneal dialysis therapy if needed, and stated they completed treatment using manuals on the night of the reported event.The pdrn confirmed the cycler set (cassette) used was no longer available to be returned for investigation.
 
Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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.
director, quality systems
900 w zaragosa drive suite d
pharr TX 78577
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key19174625
MDR Text Key341702831
Report Number0008030665-2024-00397
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00840861100750
UDI-Public00840861100750
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173718
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number050-87216
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received04/21/2024
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 Number1
Treatment
LIBERTY SELECT CYCLER.; LIBERTY SELECT CYCLER.; PD SOLUTION.; PD SOLUTION.
Patient Age66 YR
Patient SexFemale
Patient Weight82 KG
-
-