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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 12/02/2022
Event Type  malfunction  
Event Description
A hemodialysis (hd) clinic manager (cm) reported a combi set blood leak occurred thirty minutes into a patient¿s hd treatment.It was reported the blood tubing during the twisting of the lines during access flow testing came apart and the patient lost approximately 300 ml of blood.Upon follow-up, the cm confirmed the reported event.There were no machine alarms during the treatment as blood did not come into contact with the blood leak detector.There was no visible damage identified prior to treatment.There were no leaks noted during the priming, and no irregularities were identified on the combi set.The patient¿s estimated blood loss (ebl) was confirmed to be 300 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 did complete their treatment on the same machine following the event after setting up with new supplies.The combi set was available to be returned for evaluation.
 
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A hemodialysis (hd) clinic manager (cm) reported a combi set blood leak occurred thirty minutes into a patient¿s hd treatment.It was reported the blood tubing during the twisting of the lines during access flow testing came apart and the patient lost approximately 300 ml of blood.Upon follow-up, the cm confirmed the reported event.There were no machine alarms during the treatment as blood did not come into contact with the blood leak detector.There was no visible damage identified prior to treatment.There were no leaks noted during the priming, and no irregularities were identified on the combi set.The patient¿s estimated blood loss (ebl) was confirmed to be 300 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 did complete their treatment on the same machine following the event after setting up with new supplies.The combi set was available to be returned for evaluation.
 
Manufacturer Narrative
Additional information: d9, h3 plant investigation: the device was not returned to the manufacturer to date.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.
 
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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
900 w zaragosa drive suite d
pharr TX 78577
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key15946750
MDR Text Key305263715
Report Number0008030665-2022-01482
Device Sequence Number1
Product Code KOC
UDI-Device Identifier00840861100316
UDI-Public00840861100316
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 Administrator/Supervisor
Type of Report Initial,Followup
Report Date 01/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2022
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 Number21SR01800
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received01/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/20/2021
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 DIALYZER; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
Patient Age52 YR
Patient SexMale
Patient Weight102 KG
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