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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); Dyspnea (1816); Peritonitis (2252)
Event Date 02/10/2024
Event Type  Injury  
Event Description
It was reported to fresenius that a patient on peritoneal dialysis (pd) had peritonitis.In additional follow-up, the patient¿s pd nurse stated the patient was experiencing symptoms of abdominal pain and shortness of breath.As a result, on (b)(6) 2024, the patient was admitted to the hospital.Per the nurse, the patient had a pd culture obtained which grew the bacteria staphylococcus aureus and had an elevated white blood cell (wbc) count.Additionally, the patient had fluid volume overload in the setting of pre-existing chronic congestive heart failure.The nurse stated the patient was treated with intra-peritoneal (ip) antibiotic therapy and dialysis (all details unknown) while hospitalized.Subsequently, on (b)(6) 2024, the patient was discharged and was reportedly recovering from the event.The patient was continuing pd therapy with the same cycler without any adverse effects or further issues.The patient¿s nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis and fluid overload event.The nurse indicated the peritonitis is suspected to be due to a breach in aseptic technique during the pd exchange.Additionally, the nurse indicated the fluid volume overload event was due to patient non-compliance to pd therapy.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between pd therapy with the liberty cycler set and the patient¿s hospitalization for peritonitis and fluid volume overload.However, currently there is no allegation nor any objective evidence that a liberty cycler set malfunction or product deficiency was associated with these events.The patient¿s pd nurse reported the patient is non-compliant to pd therapy which is a known risk factor for fluid volume overload in patients with renal failure on dialysis.Moreover, peritonitis is a well-documented complication in patients undergoing pd therapy.The patient¿s pd culture grew the bacteria staphylococcus aureus which is bacteria normally found on human skin.Therefore, based on the reported information, the peritonitis event can be reasonably attributed to a breach in aseptic technique during the pd exchange, as reported by the pd nurse.
 
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 to fresenius that a patient on peritoneal dialysis (pd) had peritonitis.In additional follow-up, the patient¿s pd nurse stated the patient was experiencing symptoms of abdominal pain and shortness of breath.As a result, on (b)(6) 2024, the patient was admitted to the hospital.Per the nurse, the patient had a pd culture obtained which grew the bacteria staphylococcus aureus and had an elevated white blood cell (wbc) count.Additionally, the patient had fluid volume overload in the setting of pre-existing chronic congestive heart failure.The nurse stated the patient was treated with intra-peritoneal (ip) antibiotic therapy and dialysis (all details unknown) while hospitalized.Subsequently, on (b)(6) 2024, the patient was discharged and was reportedly recovering from the event.The patient was continuing pd therapy with the same cycler without any adverse effects or further issues.The patient¿s nurse confirmed the patient did not have any fluid leaks or issues with fresenius products in relation to the peritonitis and fluid overload event.The nurse indicated the peritonitis is suspected to be due to a breach in aseptic technique during the pd exchange.Additionally, the nurse indicated the fluid volume overload event was due to patient non-compliance to pd therapy.
 
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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 Key18927166
MDR Text Key337944424
Report Number0008030665-2024-00277
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,Followup
Report Date 03/26/2024
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 Not provided
Initial Date FDA Received03/18/2024
Supplement Dates Manufacturer Received03/21/2024
Supplement Dates FDA Received03/26/2024
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; Hospitalization;
Patient Age46 YR
Patient SexMale
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