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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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ERIKA DE REYNOSA, S.A. DE C.V. FMC BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number UNKNOWN- FMC BLOODLINE
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) reported to fresenius technical services that a patient's hemodialysis (hd) treatment was discontinued after blood coagulated in the bloodlines.The biomed stated that the event occurred on a treatment day when the whole local area was influenced by electrical power surges from the electrical company for over 2 and a half hours.The patient was being treated on a fresenius 2008t machine which alarmed with an e.02 alarm/message on the blood pump display which the biomed attributed to the power surges.Additional information was requested, however a response was not received.It could not be confirmed whether the blood coagulation was attributed to the power surges experienced by the user facility on the day of the event.It was initially reported that the patient did not experience an adverse event, serious injury, or require medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) was not provided.The bloodlines were not returned to the manufacturer for a physical evaluation.
 
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 (biomed) reported to fresenius technical services that a patient's hemodialysis (hd) treatment was discontinued after blood coagulated in the bloodlines.The biomed stated that the event occurred on a treatment day when the whole local area was influenced by electrical power surges from the electrical company for over 2 and a half hours.The patient was being treated on a fresenius 2008t machine which alarmed with an e.02 alarm/message on the blood pump display which the biomed attributed to the power surges.Additional information was requested, however a response was not received.It could not be confirmed whether the blood coagulation was attributed to the power surges experienced by the user facility on the day of the event.It was initially reported that the patient did not experience an adverse event, serious injury, or require medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) was not provided.The bloodlines were not returned to the manufacturer for a physical evaluation.
 
Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the customer for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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
FMC BLOODLINE
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 Key12909830
MDR Text Key283602751
Report Number8030665-2021-01805
Device Sequence Number1
Product Code FJK
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/10/2021
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 Catalogue NumberUNKNOWN- FMC BLOODLINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 11/08/2021
Initial Date FDA Received12/01/2021
Supplement Dates Manufacturer Received12/01/2021
Supplement Dates FDA Received12/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
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