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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE MTS SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE MTS SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 050-50758
Device Problem Fluid Leak (1250)
Patient Problems Abdominal Pain (1685); Peritonitis (2252)
Event Date 12/08/2021
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: there is a temporal and possible casual relationship between the use of the stay safe mts set and the patient event of peritonitis. However, the set is not available to return for evaluation by the manufacturer and there are no photographs sent to show the leak. The patient had reported multiple leaks with two different lots. It is unknown which lot is related to the peritonitis event. The culture resulted positive for acinetobacter radioresistens which can be found in moist skin areas which could also suggest a possibility of a breach in aseptic technique occurred. Based on the available information, the exact cause of the patient¿s peritonitis cannot be determined. The stay safe mts set cannot be excluded as causing or contributing to the peritonitis event. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
It was reported that a peritoneal dialysis (pd) patient was diagnosed with peritonitis. Upon follow up, the pd registered nurse (pdrn) reported the patient was seen in the pd clinic with complaints of abdominal pain. A pd effluent culture was obtained, and the patient was diagnosed with peritonitis. The patient was initiated on intraperitoneal (ip) antibiotics with vancomycin 2g and ceftazidime 2g. The patient continued with ip ceftazidime daily and received a second dose of vancomycin on (b)(6) 2021. The pd effluent culture resulted positive for acinetobacter radioresistens. The vancomycin was discontinued, and the patient has continued to take ceftazidime 2g daily. The cause of the patient¿s peritonitis event was attributed to the reported leak of the stay safe mts set. The patient was not hospitalized for this event and continues to complete treatment utilizing the liberty select cycler.
 
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Brand NameSTAY SAFE MTS SET
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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
1100 e, military hwy, suite c
pharr TX 78577
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key13099959
MDR Text Key285174474
Report Number8030665-2021-01920
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904806
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number050-50758
Device Catalogue Number050-50758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received01/11/2022
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 Treatment Data
Date Received: 12/28/2021 Patient Sequence Number: 1
Treatment
DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
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