• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 03-2722-9
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/07/2023
Event Type  malfunction  
Event Description
A corporate inventory manager reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow-up with a registered nurse (rn) from the facility who was present at the time of the event.Per the rn, approximately one hour into the hd treatment, blood was seen dripping externally from the venous end of the dialyzer where the custom combi set was connected.There were no obvious defects noted at the connection point, and the rn confirmed that the bloodline seemed to be securely connected to the dialyzer.There were no alarms from the machine, a fresenius 2008t machine.It was confirmed that there was no leaking noticed during the priming phase.Once the blood leak was noticed, the treatment was stopped.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The patient was re-setup with new supplies on a different machine where they were able to complete the treatment.The rn 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 bloodlines were not available to be returned for evaluation as they were reportedly discarded.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A corporate inventory manager reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow-up with a registered nurse (rn) from the facility who was present at the time of the event.Per the rn, approximately one hour into the hd treatment, blood was seen dripping externally from the venous end of the dialyzer where the custom combi set was connected.There were no obvious defects noted at the connection point, and the rn confirmed that the bloodline seemed to be securely connected to the dialyzer.There were no alarms from the machine, a fresenius 2008t machine.It was confirmed that there was no leaking noticed during the priming phase.Once the blood leak was noticed, the treatment was stopped.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The patient was re-setup with new supplies on a different machine where they were able to complete the treatment.The rn 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 bloodlines were not available to be returned for evaluation as they were reportedly discarded.
 
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 facility for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combi set 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
900 w zaragosa drive suite d
pharr TX 78577
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key18422379
MDR Text Key331684138
Report Number0008030665-2023-01191
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 Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 02/16/2024
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 Number03-2722-9
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 12/14/2023
Initial Date FDA Received12/29/2023
Supplement Dates Manufacturer Received01/31/2024
Supplement Dates FDA Received02/16/2024
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; FRESENIUS OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
Patient Age73 YR
Patient SexFemale
Patient Weight83 KG
-
-