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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
Catalog Number 050-95005
Device Problem Fluid Leak (1250)
Patient Problem Peritonitis (2252)
Event Date 03/28/2019
Event Type  Injury  
Manufacturer Narrative
Clinical review: a clinical investigation was performed. Based on the available information, the fresenius safe lock 18-inch tubing set cannot be excluded as a causal/contributory factor in the patient¿s peritonitis event. Anytime there is a breach in the aseptic pd pathway there is a risk of contamination with bacteria that can lead to a peritonitis infection in pd patients. At this time, it cannot be determined what exactly caused the fluid leak to occur with this product as the manufacturer product investigation is currently pending. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A peritoneal dialysis (pd) nurse reported to fresenius customer service that a stay safe luer lock has droplets all over the tubing at the end of treatment, it appears to have no issue until pressure is applied. The pdrn stated the patient discontinued treatment due to fluid on their bed. The patient was prescribed antibiotics and a culture of the fluid was taken. Upon follow up, the peritoneal dialysis nurse (pdrn) confirmed the fluid leak. The pdrn stated that the fluid leak came from the stay safe luer lock between the line segment. The pdrn stated that the patient developed peritonitis from the fluid leak that occurred during fill and drain phases of the patient¿s peritoneal dialysis treatment. The patient was not hospitalized. The pdrn stated that the patient experienced the fluid leak on (b)(6) 2019 and presented in the clinic on (b)(6) 2019. The patient has cloudy effluent. The pdrn stated that a pd culture was performed. The pdrn stated that the organism was staphylococcus epidermidis. The patient was prescribed vancomycin (2 grams, intraperitoneal) and oral cipro, 500mg once a day. The pdrn stated that the patient is continuing treatment on the cycler. The pdrn stated the sample was available for return for physical evaluation by the manufacturer.
 
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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 Key8496870
MDR Text Key141374085
Report Number8030665-2019-00562
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 05/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number050-95005
Device Lot Number18ER08109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received05/17/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2018
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: 04/09/2019 Patient Sequence Number: 1
Treatment
DELFLEX PD FLUID; LIBERTY CYCLER SET 
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