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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number 03-2722-9
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2020
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, 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
It was reported that the heparin line of the combi set bloodlines detached from the main tubing of the bloodlines during a patient's hemodialysis (hd) tubing causing a blood leak.Upon follow-up with the hd nurse, it was reported that the blood leak occurred about 1 hour into treatment.It was reported there was no defect or damage seen on the bloodlines and there were no loose connections, or any issues discovered during priming.The patient's estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The bloodlines used during treatment are not available to be returned to the manufacturer for evaluation because they were discarded.
 
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Brand Name
CUSTOM COMBI SET
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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 Key10207055
MDR Text Key200228860
Report Number8030665-2020-00901
Device Sequence Number1
Product Code FJK
UDI-Device Identifier00840861100293
UDI-Public00840861100293
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Model Number03-2722-9
Device Catalogue Number03-2722-9
Device Lot Number20CR01313
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 06/11/2020
Initial Date FDA Received06/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age61 YR
Patient Weight105
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