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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 Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Peritonitis (2252)
Event Date 01/05/2024
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: there is a temporal relationship between pd therapy utilizing the liberty select cycler with liberty cycler set and the patient event of peritonitis with hospitalization.However, there is no documentation in the complaint record to show a causal relationship between the use of the liberty select cycler and cycler set and the peritonitis event.Regardless of any allegation of a device malfunction or deficiency, or cycler set defect reported for this peritonitis event, there was a report of a solution bag leak (not a medical device) during set-up of the patient¿s pd treatment.The spouse re-set up the treatment with a new solution bag and connector but did not replace the cassette which could have come into contact with the leaking solution resulting in the patient¿s peritonitis.This cannot be confirmed as the culture resulted in negative growth, which sometimes occurs in patients with clinical findings of peritonitis.The most common cause of culture-negative cases is initiation of antibiotics before cultures are obtained.Although the cause of the peritonitis was not identified, most cases of pd peritonitis result from touch contamination of the catheter or the connections, which could have occurred during set-up of the patient¿s treatment.Based on the available 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 peritonitis event.
 
Event Description
A peritoneal dialysis registered nurse (pdrn) contacted fresenius customer service on (b)(6) 2024 to report this peritoneal dialysis (pd) patient was hospitalized with a diagnosis of peritonitis.Additional information was obtained through follow-up with the peritoneal dialysis registered nurse (pdrn) on (b)(6) 2024.The patient called the pd clinic on (b)(6) 2024 with complaints of weakness and low blood pressure.Additionally, the patient was below dry weight (weight not provided).The patient did not report any abdominal pain.The pdrn stated the patient has a history of pulling off too much fluid during treatments and the clinic thought he may be dehydrated.The patient was instructed to go to the emergency room (er) for evaluation.Bloodwork was obtained.The patient¿s white blood cell count was 329 with 49% polymorphonuclear cells.The patient had urine and blood cultures taken.The patient was admitted to the hospital and diagnosed with peritonitis based on the lab values.The patient was initiated on antibiotic therapy with vancomycin (route, dose, and frequency unknown).The cultures were both negative for growth.The patient was discharged from the hospital on (b)(6) 2024.The patient continued the vancomycin with the last dose on (b)(6) 2024.The pdrn stated that during the patient¿s pd treatment on (b)(6) 2024, the initial bag of solution was leaking.The patient¿s spouse changed out the solution and connectors; however, the cassette was not changed.The pdrn stated that this could have been the cause of the patient¿s peritonitis event, but no cause had been confirmed.No further information was provided.
 
Event Description
A peritoneal dialysis registered nurse (pdrn) contacted fresenius customer service on (b)(6) 2024 to report this peritoneal dialysis (pd) patient was hospitalized with a diagnosis of peritonitis.Additional information was obtained through follow-up with the peritoneal dialysis registered nurse (pdrn) on (b)(6) 2024.The patient called the pd clinic on (b)(6) 2024 with complaints of weakness and low blood pressure.Additionally, the patient was below dry weight (weight not provided).The patient did not report any abdominal pain.The pdrn stated the patient has a history of pulling off too much fluid during treatments and the clinic thought he may be dehydrated.The patient was instructed to go to the emergency room (er) for evaluation.Bloodwork was obtained.The patient¿s white blood cell count was 329 with 49% polymorphonuclear cells.The patient had urine and blood cultures taken.The patient was admitted to the hospital and diagnosed with peritonitis based on the lab values.The patient was initiated on antibiotic therapy with vancomycin (route, dose, and frequency unknown).The cultures were both negative for growth.The patient was discharged from the hospital on (b)(6) 2024.The patient continued the vancomycin with the last dose on (b)(6) 2024.The pdrn stated that during the patient¿s pd treatment on (b)(6) 2024, the initial bag of solution was leaking.The patient¿s spouse changed out the solution and connectors; however, the cassette was not changed.The pdrn stated that this could have been the cause of the patient¿s peritonitis event, but no cause had been confirmed.No further information was provided.
 
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 Key18560890
MDR Text Key333435432
Report Number0008030665-2024-00077
Device Sequence Number1
Product Code FKX
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 02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2024
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
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/21/2024
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) Hospitalization; Required Intervention;
Patient Age64 YR
Patient SexMale
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