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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); Diarrhea (1811); Peritonitis (2252)
Event Date 02/27/2024
Event Type  Injury  
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between ccpd therapy utilizing the liberty cycler set and the serious adverse events of peritonitis, characterized by abdominal pain and cloudy effluent fluid, which required hospitalization and antibiotic therapy.The pdrn attributed causality to a touch contamination event involving poor hand hygiene.The patient suffers from chronic diarrhea and admits to using the restroom at night and failing to perform hand hygiene prior to resuming treatment.Per the pdrn, the events were unrelated to the patient¿s utilization of any fresenius product(s) and/or device(s).Klebsiella is most frequently found in the gi tract and in feces.Based on the information available, 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) deficiency or malfunction caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product failed to meet the users¿ expectations or the manufacturers¿ specifications.Individuals undergoing pd for rrt (manual or cycler based) are at high risk for infections of the peritoneum.
 
Event Description
On 13/mar/2024, fresenius became aware this patient with end stage renal disease (esrd) previously on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was hospitalized and diagnosed with peritonitis on (b)(6) 2024.Follow-up with the patient¿s pd registered nurse [(pd)rn] confirmed the patient presented to the emergency room on (b)(6) 2024 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc elevated, result not provided) were collected, and the patient was diagnosed with peritonitis.Once admitted, the patient was treated with intraperitoneal (ip) vancomycin 1000 mg (single dose) and ip cefepime 1000 mg daily for 14 days.The patient¿s peritoneal effluent culture result returned positive for klebsiella oxytoca on approximately 2/mar/2024 and the patient¿s vancomycin was discontinued.The patient continued to undergo ccpd therapy while hospitalized without reported issue and was discharged home on (b)(6) 2024 in stable condition.The pdrn attributed causality to a touch contamination event involving poor hand hygiene.The patient suffers from chronic diarrhea, and admitted she used the restroom at night and failed to perform hand hygiene before reconnecting.Per the pdrn, the events were unrelated to the patient¿s utilization of any fresenius product(s) and/or device(s).The patient has recovered from the serious adverse events and continues to undergo ccpd utilizing the same liberty select cycler without reported issue.
 
Manufacturer Narrative
Additional information: 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
On 13/mar/2024, fresenius became aware this patient with end stage renal disease (esrd) previously on continuous cyclic peritoneal dialysis [cc(pd)] utilizing a liberty select cycler for renal replacement therapy (rrt) was hospitalized and diagnosed with peritonitis on (b)(6) 2024.Follow-up with the patient¿s pd registered nurse [(pd)rn] confirmed the patient presented to the emergency room on (b)(6) 2024 with complaints of abdominal pain and cloudy peritoneal effluent fluid.A peritoneal effluent fluid culture and cell count (wbc elevated, result not provided) were collected, and the patient was diagnosed with peritonitis.Once admitted, the patient was treated with intraperitoneal (ip) vancomycin 1000 mg (single dose) and ip cefepime 1000 mg daily for 14 days.The patient¿s peritoneal effluent culture result returned positive for klebsiella oxytoca on approximately (b)(6) 2024 and the patient¿s vancomycin was discontinued.The patient continued to undergo ccpd therapy while hospitalized without reported issue and was discharged home on (b)(6) 2024 in stable condition.The pdrn attributed causality to a touch contamination event involving poor hand hygiene.The patient suffers from chronic diarrhea, and admitted she used the restroom at night and failed to perform hand hygiene before reconnecting.Per the pdrn, the events were unrelated to the patient¿s utilization of any fresenius product(s) and/or device(s).The patient has recovered from the serious adverse events and continues to undergo ccpd utilizing the same liberty select cycler without reported issue.
 
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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 Key18942322
MDR Text Key338145040
Report Number0008030665-2024-00282
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 03/21/2024
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 03/13/2024
Initial Date FDA Received03/20/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates 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
LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; PD SOLUTION; PD SOLUTION
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age66 YR
Patient SexFemale
Patient Weight54 KG
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