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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 Low Blood Pressure/ Hypotension (1914)
Event Date 03/18/2022
Event Type  malfunction  
Event Description
A user facility clinic manager (cm) reported a blood leak that occurred with a combiset approximately 150 minutes into the patient¿s hemodialysis (hd) treatment.The arterial pressure was high and pushed into the heparin line.The plunger dislodged and blood began squirting out of the transfusor.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury or adverse event associated with this event.The patient was hypotensive as a result of the blood leak and saline was administered (per standing order).The patient successfully completed treatment on the same machine with new supplies.There was no defect, damage, or loose connections noted on the combiset.The complaint sample was reported to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Manufacturer Narrative
Additional information: d9, h3 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
A user facility clinic manager (cm) reported a blood leak that occurred with a combiset approximately 150 minutes into the patient¿s hemodialysis (hd) treatment.The arterial pressure was high and pushed into the heparin line.The plunger dislodged and blood began squirting out of the transfusor.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury or adverse event associated with this event.The patient was hypotensive as a result of the blood leak and saline was administered (per standing order).The patient successfully completed treatment on the same machine with new supplies.There was no defect, damage, or loose connections noted on the combiset.The complaint sample was reported to be available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Additional information: d9, h3 plant investigation: the manufacturer received the complaint product sample with original packaging identified with product number 03-2722-9 and lot number 21nr01152.During visual inspection with a microscope a channel leak was found in the assembly of the heparin line to the red ¿t¿ connector.The sample was tested via simulated use and a leak was found 40 minutes after treatment initiation at the assembly of heparin line to red ¿t¿ connector.The alleged failure mode ¿leak at the heparin line¿ was confirmed during sample evaluation.This kind of failure mode could be attributed to an improper assembly by the operator due to not following the work instruction, does not applying solvent correctly in the components during the manufacturing process (lack of solvent application), or due to a lack of solvent during the assembly of the components (dispenser malfunctioning).
 
Event Description
A user facility clinic manager (cm) reported a blood leak that occurred with a combiset approximately 150 minutes into the patient¿s hemodialysis (hd) treatment.The arterial pressure was high and pushed into the heparin line.The plunger dislodged and blood began squirting out of the transfusor.The patient¿s estimated blood loss (ebl) was approximately 200 ml.There was no patient injury or adverse event associated with this event.The patient was hypotensive as a result of the blood leak and saline was administered (per standing order).The patient successfully completed treatment on the same machine with new supplies.There was no defect, damage, or loose connections noted on the combiset.The complaint sample was reported to be available to be returned to the manufacturer for physical evaluation.
 
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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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key13938777
MDR Text Key288107191
Report Number8030665-2022-00312
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 Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 07/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number03-2722-9
Device Catalogue Number03-2722-9
Device Lot Number21NR01152
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2021
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 2008T MACHINE.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.
Patient Age79 YR
Patient SexFemale
Patient Weight106 KG
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