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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
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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Peritonitis (2252)
Event Date 04/01/2024
Event Type  Injury  
Event Description
It was reported that a patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] was diagnosed with peritonitis.Attempts to obtain additional clinical information (e.G., discharge summary, organism, causality, patient demographics) were unsuccessful.
 
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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 Key19140763
MDR Text Key340563992
Report Number3023981687-2024-00099
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
Report Date 04/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number050-87216
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/18/2024
Distributor Facility Aware Date04/04/2024
Device AgeMO
Event Location Home
Date Report to Manufacturer04/18/2024
Date Manufacturer Received04/04/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DELFLEX PD FLUID; LIBERTY SELECT CYCLER
Patient Outcome(s) Required Intervention;
Patient SexMale
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