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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A user facility clinic manager (cm) reported that a blood clot formed at the connection between the fresenius bloodlines and the fistula needle (a non-fresenius product) during a patient¿s hemodialysis (hd) treatment.The issue was discovered approximately one hour into treatment when the nursing staff noticed the arterial pressure was high.The nurse attempted to readjust the needle to address the issue.Treatment was paused as the staff experienced difficulty moving the needle.The nurse bent the needle in order to detach it from the bloodlines at which point a clot was found at the point of connection.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was recannulated and treatment was completed on the same machine with new supplies.The patient¿s estimated blood loss (ebl) was requested from the user facility but was not provided.The complaint device was discarded and is not available to be returned to the manufacturer for 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.
 
Event Description
A user facility clinic manager (cm) reported that a blood clot formed at the connection between the fresenius bloodlines and the fistula needle (a non-fresenius product) during a patient¿s hemodialysis (hd) treatment.The issue was discovered approximately one hour into treatment when the nursing staff noticed the arterial pressure was high.The nurse attempted to readjust the needle to address the issue.Treatment was paused as the staff experienced difficulty moving the needle.The nurse bent the needle in order to detach it from the bloodlines at which point a clot was found at the point of connection.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was recannulated and treatment was completed on the same machine with new supplies.The patient¿s estimated blood loss (ebl) was requested from the user facility but was not provided.The complaint device was discarded and is not 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
MDR Report Key12130896
MDR Text Key260451797
Report Number8030665-2021-01114
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,consum
Type of Report Initial,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
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
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received07/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
Patient Weight76
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