• 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
Model Number 050-87216
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Urinary Tract Infection (2120); Peritonitis (2252)
Event Date 04/20/2023
Event Type  Injury  
Event Description
On (b)(6) 2023 this peritoneal dialysis (pd) patient called fresenius technical support to inquire what to do after discovering lots of fibrin in the patient line.The patient was advised to contact their peritoneal dialysis registered nurse (pdrn).Upon follow-up, the patient stated they were diagnosed with peritonitis.Additional information was provided by the pdrn.On (b)(6) 2023 the patient was feeling nauseated and went to the emergency room (er).The patient was treated for a urinary tract infection (uti) with rocephin (dose, route, frequency, and duration unknown).Additionally, the patient was found to have electrolyte imbalances (low sodium, magnesium, and potassium).The patient was kept in the er overnight and released the next morning once the nausea ceased.The pdrn stated the uti and electrolyte imbalances were unrelated to pd therapy or any fresenius products.The patient was then seen in the pd clinic where pd effluent cultures were obtained.The cultures returned positive for staphylococcus epidermidis.The patient was prescribed intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown) for the peritonitis episode.The pdrn stated that based on the culture results, touch contamination is the likely cause of the patient¿s peritonitis event.No further information was provided.
 
Event Description
On (b)(6) 2023, this peritoneal dialysis (pd) patient called fresenius technical support to inquire what to do after discovering lots of fibrin in the patient line.The patient was advised to contact their peritoneal dialysis registered nurse (pdrn).Upon follow-up, the patient stated they were diagnosed with peritonitis.Additional information was provided by the pdrn.On (b)(6) 2023, the patient was feeling nauseated and went to the emergency room (er).The patient was treated for a urinary tract infection (uti) with rocephin (dose, route, frequency, and duration unknown).Additionally, the patient was found to have electrolyte imbalances (low sodium, magnesium, and potassium).The patient was kept in the er overnight and released the next morning once the nausea ceased.The pdrn stated the uti and electrolyte imbalances were unrelated to pd therapy or any fresenius products.The patient was then seen in the pd clinic where pd effluent cultures were obtained.The cultures returned positive for staphylococcus epidermidis.The patient was prescribed intraperitoneal (ip) vancomycin and ceftazidime (dose, frequency, and duration unknown) for the peritonitis episode.The pdrn stated that based on the culture results, touch contamination is the likely cause of the patient¿s peritonitis event.No further information was provided.
 
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
MDR Report Key16901887
MDR Text Key314898847
Report Number3023981687-2023-00096
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 Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/10/2023,05/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number050-87216
Device Catalogue Number050-87212
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/10/2023
Distributor Facility Aware Date04/19/2023
Device AgeMO
Event Location Home
Date Report to Manufacturer05/10/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/10/2023
Supplement Dates Manufacturer Received05/16/2023
Supplement Dates FDA Received05/17/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DEFLEX PD FLUID; DEFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
Patient Outcome(s) Hospitalization; Required Intervention;
Patient SexFemale
-
-