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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
Model Number 050-87216
Device Problem Material Puncture/Hole (1504)
Patient Problems Abdominal Pain (1685); Peritonitis (2252)
Event Date 02/19/2023
Event Type  Injury  
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 (<24 hours) and antibiotic therapy.The outpatient cm attributed causality to a hole discovered in a liberty cycler set utilized by the patient the evening prior.Esrd patients undergoing pd therapy (manual or cycler based) for rrt are at high risk for infections of the peritoneum.Based on the information available, the patient¿s liberty cycler set cannot be disassociated from the events.Given the reported leak by the patient, confirmation of the deficiency by the cm, lack of organism, and no manufacturer evaluation/investigation of the suspect product.The liberty cycler set cannot be excluded from having a possible causal and/or contributory role in the serious adverse events.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to peritonitis.Follow-up with the outpatient clinical manager (cm) confirmed the patient presented to the emergency room on (b)(6) 2023 with abdominal pain.A peritoneal effluent fluid culture and cell count (requested, results unavailable) were collected, and the patient was diagnosed with peritonitis.The patient was started on intraperitoneal (ip) vancomycin 2000 mg every 5 days for 21 days, ceftazidime 1000 mg daily for 21 days and was discharged home <24 hours later.The patient resumed ccpd therapy following discharge (same cycler) and is recovering from the events.Causality was attributed to a hole discovered on the patient line of the cycler set the patient utilized on (b)(6) 2023.The cm stated the patient is very adept at performing pd therapy, after performing spouse's pd therapy for years.
 
Event Description
A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)] for renal replacement therapy (rrt) was hospitalized due to peritonitis.Follow-up with the outpatient clinical manager (cm) confirmed the patient presented to the emergency room on (b)(6) 2023 with abdominal pain.A peritoneal effluent fluid culture and cell count (requested, results unavailable) were collected, and the patient was diagnosed with peritonitis.The patient was started on intraperitoneal (ip) vancomycin 2000 mg every 5 days for 21 days, ceftazidime 1000 mg daily for 21 days and was discharged home <24 hours later.The patient resumed ccpd therapy following discharge (same cycler) and is recovering from the events.Causality was attributed to a hole discovered on the patient line of the cycler set the patient utilized on (b)(6) 2023.The cm stated the patient is very adept at performing pd therapy, after performing spouse's pd therapy for years.
 
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.
 
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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 Key16565424
MDR Text Key311512156
Report Number0008030665-2023-00288
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,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/11/2023
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? Yes
Device Operator Lay User/Patient
Device Model Number050-87216
Device Catalogue Number050-87216
Device Lot Number22LR08068
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 03/02/2023
Initial Date FDA Received03/17/2023
Supplement Dates Manufacturer Received03/30/2023
Supplement Dates FDA Received04/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/29/2022
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) Hospitalization; Required Intervention;
Patient Age62 YR
Patient SexFemale
Patient Weight105 KG
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