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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 Problems Abdominal Pain (1685); Peritonitis (2252)
Event Date 02/20/2024
Event Type  Injury  
Event Description
A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] was hospitalized due to peritonitis.No additional information was provided during intake.During follow-up, the patient¿s pd registered nurse (pdrn) reported the patient presented to the emergency room on (b)(6) 2024 with complaints of abdominal pain.A peritoneal effluent fluid culture and cell count (wbc elevated, results unavailable) were collected, and the patient was diagnosed with peritonitis.The patient was treated with intraperitoneal (ip) cefepime 1500 mg daily, and vancomycin 1500 mg every three days for 21 days.However, on (b)(6) 2024, the patient¿s peritoneal effluent culture result returned positive for staphylococcus aureus, and the patient¿s cefepime was discontinued.The patient was discharged on (b)(6) 2024 and has recovered from the serious adverse events.The patient continued to undergo ccpd therapy while hospitalized and resumed utilizing the same liberty select cycler at home without reported issue.The pdrn attributed causality to a touch contamination event, as the patient admitted he occasionally does not perform hand hygiene prior to initiating and/or terminating treatment.Per the pdrn, the events were unrelated to any fresenius product(s) and/or device(s) deficiency or malfunction.
 
Manufacturer Narrative
Clinical review: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the serious adverse events of peritonitis (characterized by abdominal pain), which warranted hospitalization and antibiotic therapy.The pdrn attributed causality to a touch contamination event, as the patient admitted he occasionally does not perform hand hygiene prior to initiating and/or terminating treatment.Per the pdrn, the serious adverse events were unrelated to the patient¿s utilization of a fresenius device(s) and/or product(s).Staphylococcus aureus is commonly found in the mucus membranes and skin of humans and is the most frequent organism associated with peritoneal infections in pd patients.The liberty cycler set can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.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.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.
 
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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 Key18956506
MDR Text Key338309250
Report Number0008030665-2024-00292
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 Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/22/2024
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
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 03/06/2024
Initial Date FDA Received03/21/2024
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
DELFLEX PD FLUID; LIBERTY SELECT CYCLER
Patient Outcome(s) Required Intervention;
Patient Age43 YR
Patient SexMale
Patient Weight127 KG
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