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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
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ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS Back to Search Results
Model Number 03-2794-0
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/09/2022
Event Type  malfunction  
Event Description
A user facility clinical manager (cm) reported a combi set blood leak that occurred at the very beginning of a patient¿s hemodialysis (hd) treatment.Blood was observed leaking externally from the connection of the venous chamber to the venous line.There were no machine alarms.No defect or damage was noted at the location of the leak.It was confirmed that there were no changes in pressure.It was also confirmed that there was no leaking during the priming phase.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was 100 to 150 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed treatment after being resetup with new supplies on the same machine.The complaint device was reportedly available to be returned for manufacturer evaluation.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Manufacturer Narrative
Plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.Therefore, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review 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
A user facility clinical manager (cm) reported a combi set blood leak that occurred at the very beginning of a patient¿s hemodialysis (hd) treatment.Blood was observed leaking externally from the connection of the venous chamber to the venous line.There were no machine alarms.No defect or damage was noted at the location of the leak.It was confirmed that there were no changes in pressure.It was also confirmed that there was no leaking during the priming phase.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was 100 to 150 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed treatment after being resetup with new supplies on the same machine.The complaint device was reportedly available to be returned for manufacturer evaluation.
 
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Brand Name
COMBISET ACCESS FLOW REVERSE CON TWISTER
Type of Device
ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key15794911
MDR Text Key303666598
Report Number0008030665-2022-01382
Device Sequence Number1
Product Code KOC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022536
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 12/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03-2794-0
Device Catalogue Number03-2794-0
Device Lot Number21NR01167
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received12/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2021
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
FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
Patient Age69 YR
Patient SexFemale
Patient Weight86 KG
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