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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.
 
Manufacturer Narrative
Clinical review: a possible temporal relationship exists between ccpd therapy utilizing the liberty select cycler, liberty cycler set and the serious adverse event of peritonitis.The etiology of the peritonitis is currently unknown; therefore, causality cannot firmly be established.However, during intake the pdrn reported the peritonitis event did not require any fresenius device(s) and/or product(s) to be replaced.Additionally, the pdrn did not report the patient was experiencing any issues related to a fresenius device(s) and/or product(s).Those individuals undergoing pd therapy (manual or cycler based) are at high risk for infections of the peritoneum.Based on the information available, the patient¿s liberty select cycler and liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius product(s) and/or device(s) caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations or manufacturers¿ specifications.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the patient for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius liberty cycler sets shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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.
 
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
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 Key19140761
MDR Text Key340561752
Report Number0008030665-2024-00379
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Device AgeMO
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/18/2024
Supplement Dates Manufacturer Received04/24/2024
Supplement Dates FDA Received05/01/2024
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
DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
Patient Outcome(s) Required Intervention;
Patient SexMale
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