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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 03/27/2020
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (bmt) reported that a combi set blood leak occurred immediately at the onset of a patient¿s hemodialysis (hd) treatment.The arterial line reportedly ¿popped out¿ (or separated) from the connector of the combi set, which remained screwed onto the dialyzer.The separation was immediately recognized by the operator, and the treatment was stopped.There were no leaks observed during the priming phase, and nothing unusual was noted with the combi set prior to use.The separation resulted in approximately 300 ml of blood loss.The patient was dialyzing on a fresenius 2008t machine and was using a fresenius optiflux dialyzer.There were no machine alarms reported.The patient completed their treatment after being re-setup with new supplies on a different machine.It was 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 sample was reportedly available to be returned for a manufacturer evaluation.
 
Manufacturer Narrative
Additional information: b5, d10, 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 biomedical technician (bmt) reported that a combi set blood leak occurred immediately at the onset of a patient¿s hemodialysis (hd) treatment.The arterial line reportedly ¿popped out¿ (or separated) from the connector of the combi set, which remained screwed onto the dialyzer.The separation was immediately recognized by the operator, and the treatment was stopped.There were no leaks observed during the priming phase, and nothing unusual was noted with the combi set prior to use.The separation resulted in approximately 300 ml of blood loss.The patient was dialyzing on a fresenius 2008t machine and was using a fresenius optiflux dialyzer.There were no machine alarms reported.The patient completed their treatment after being re-setup with new supplies on a different machine.It was 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 sample was reportedly available to be returned for a manufacturer evaluation.Additional follow up revealed that the sample was discarded and is therefore not available to be returned for manufacturer 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
MDR Report Key9993940
MDR Text Key188806991
Report Number8030665-2020-00544
Device Sequence Number1
Product Code FJK
UDI-Device Identifier00840861100293
UDI-Public00840861100293
Combination Product (y/n)N
PMA/PMN Number
K962081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Model Number03-2722-9
Device Catalogue Number03-2722-9
Device Lot Number19LR01212
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received04/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS 2008T MACHINE; FRESENIUS OPTIFLUX DIALYZER
Patient Age72 YR
Patient Weight98
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