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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/LUER LOCK CATHETER EXT. 18 IN. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK CATHETER EXT. 18 IN. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 050-95005
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Peritonitis (2252)
Event Date 12/28/2019
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: there is a temporal relationship between pd therapy on the liberty select cycler with cycler set and the patient event of staphylococcus capitis peritonitis. However, there is no documentation in the complaint file to show a causal relationship between the event and utilization of the liberty select cycler and cycler set. Additionally, there is no allegation of a machine malfunction or deficiency or cycler set leak reported for the peritonitis. Although the cause of the peritonitis is unknown, the culture result of staphylococcus capitis suggests a breach in aseptic technique. Staph capitis is a known organism on human skin and known to be linked with catheter-related infection. The cause of the pd catheter and extension set turning blue has not been determined. There is no literature pertaining to this scenario where the fluid remains clear without also turning blue. Based on the available information and no allegation or evidence of a malfunction, deficiency or defect the liberty select cycler and cycler set can be excluded as the cause of the patient¿s staphylococcus capitis peritonitis. 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. The initial complaint details alleged that there was an unspecified infection. Upon follow up on (b)(6) 2020, the initial reporter, the patient¿s pd clinic¿s program manager (pm), reported that the patient had presented to the local emergency room on (b)(6) 2019 for cloudy pd effluent and abdominal pain. A pd effluent culture was obtained, and the patient had a computed tomography (ct) scan without contrast. No medication was administered to the patient and they were discharged within 24 hours. On (b)(6) 2019 the patient was seen at the pd clinic. The patient was asymptomatic, and it was noted that the patient¿s pd effluent was slightly cloudy. The patient was given antibiotics vancomycin 1g and gentamycin 100mg via intraperitoneal (ip) administration and instructed to swell for 6 hours. On (b)(6) 2019 there was no growth and no organism seen on the culture after two days. On (b)(6) 2020 the patient was seen at the clinic for a follow-up appointment. Patient was asymptomatic and their pd effluent was clear. Another culture was obtained. The patient reported that his pd catheter (covidien product) and extension set (fmc product) had turned blue the previous day. The pd nurse tried to wipe the set with an alcohol rub, but no color came off the tubing. After examination by the pd nurse it was determined that the blue coloring was on the inside of the extension set and catheter. The patient¿s extension set was changed out. There were no medication changes nor consumption of unusual liquids reported. On this date the pd effluent culture results from the hospital came back positive for staphylococcus capitis. The patient was administered a dose of ip vancomycin 1500mg for 3 doses for peritonitis. On (b)(6) 2020 the pd nurse conducted a home visit and the extension set was blue again with clear pd effluent. The surgeon who implanted the catheter and the catheter manufacturer, covidien, were contacted and they indicated they were unaware of similar cases of catheters turning blue. One of the extension sets is available at the clinic and a sample return was scheduled. Once returned the sample will undergo a physical evaluation by the manufacturer. A cause was not alleged nor identified for the patient¿s peritonitis. The patient remains asymptomatic and continues to complete pd therapy on the same liberty select cycler.
 
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Brand NameSTAY SAFE/LUER LOCK CATHETER EXT. 18 IN.
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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key9646060
MDR Text Key178355086
Report Number8030665-2020-00141
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number050-95005
Device Catalogue Number050-95005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/23/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated by Manufacturer? Yes
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: 01/30/2020 Patient Sequence Number: 1
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