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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 Peritonitis (2252); Malaise (2359)
Event Date 02/12/2024
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: there is a possible temporal relationship between peritoneal dialysis (pd) utilizing the liberty select cycler with liberty cycler set and the patient event of peritonitis and sepsis with hospitalization.However, it is unknown if the cause of the peritonitis is the patient¿s pre-existing diverticulitis or some other cause.Additionally, there is no documentation in the complaint file to show a causal relationship between the adverse event and use of the liberty select cycler with liberty cycler set.There is no allegation of a device malfunction or deficiency, or cycler set defect reported for this event.The culture results have not been received by the pd clinic; therefore, the cause of the peritonitis cannot be confirmed.Although no cause of peritonitis has been determined, all pd patients are at risk of peritonitis due to a compromised immune system and the increase of potential for microbial contamination from dialysis techniques.Most cases of peritonitis are caused by touch contamination by the patient with the pd catheter being a source of entry for organisms into the peritoneum.Diverticulitis can also be a source of peritonitis.If a diverticulum becomes swollen enough to rupture (tear), it could allow intestinal bacteria to leak into your peritoneal cavity.Peritonitis can lead to sepsis.Based on the limited information and no allegation of a malfunction, deficiency, or defect the liberty select cycler and cycler set can be excluded as the cause of the patient¿s reported peritonitis and sepsis event.
 
Event Description
During a follow-up call for a heater bag not detected message, this peritoneal dialysis (pd) patient stated she was admitted to the hospital on (b)(6) 2024.The patient stated she was unsure if the hospitalization was related to the liberty select cycler, but something had happened to her pd catheter incision.Additional information was provided by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient arrived at the hospital on (b)(6) 2024 with complaints of general malaise.The patient was admitted to the hospital.The pdrn stated she was initially informed the patient was diagnosed with sepsis based on positive blood culture results.The pdrn was then updated on the patient¿s status and informed the patient was also diagnosed with peritonitis.No culture results were available to the pdrn as no hospital documentation has been received.The pdrn stated the patient has a history of diverticulitis and without culture results could not confirm if the peritonitis and subsequent sepsis was caused by the diverticulitis or due to another cause.The pdrn had no additional information related to the patient¿s hospitalization.The patient¿s report of something happening to the pd catheter incision could not be confirmed.
 
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
During a follow-up call for a heater bag not detected message, this peritoneal dialysis (pd) patient stated she was admitted to the hospital on (b)(6) 2024.The patient stated she was unsure if the hospitalization was related to the liberty select cycler, but something had happened to her pd catheter incision.Additional information was provided by the patient¿s peritoneal dialysis registered nurse (pdrn).The patient arrived at the hospital on (b)(6) 2024 with complaints of general malaise.The patient was admitted to the hospital.The pdrn stated she was initially informed the patient was diagnosed with sepsis based on positive blood culture results.The pdrn was then updated on the patient¿s status and informed the patient was also diagnosed with peritonitis.No culture results were available to the pdrn as no hospital documentation has been received.The pdrn stated the patient has a history of diverticulitis and without culture results could not confirm if the peritonitis and subsequent sepsis was caused by the diverticulitis or due to another cause.The pdrn had no additional information related to the patient¿s hospitalization.The patient¿s report of something happening to the pd catheter incision 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 Key18790455
MDR Text Key336355118
Report Number0008030665-2024-00219
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 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
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
Date Manufacturer Received03/07/2024
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) Hospitalization; Required Intervention;
Patient Age52 YR
Patient SexFemale
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