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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 Anemia (1706)
Event Date 03/05/2021
Event Type  Injury  
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.Clinical investigation: there is a temporal relationship between hd therapy utilizing the combiset and the patient blood loss due to clotting in the venous chamber requiring the administration of a blood transfusion.However, the cause of the patient¿s blood clotting has not been determined.There are several reasons for blood clotting in the extracorporeal circuit which includes inadequate anticoagulation, patient physiological issues (high hemoglobin), low blood flow or high ultrafiltration rates.No malfunction or defect was reported with the combiset and the sample was not returned for evaluation.Based on the available information, it cannot be concluded if the combiset caused the patient¿s blood to clot in the venous chamber requiring the blood transfusion; however, the use of the combiset did contribute to the adverse event which required medical intervention.
 
Event Description
A hemodialysis registered nurse (hdrn) reported to fresenius this patient experienced blood clotting inside the venous chamber of the combiset.The hdrn stated that the patient completed the scheduled hd treatment on the fresenius 2008t machine with a fresenius dialyzer when the blood had clotted inside the venous chamber of the combiset.The 2008t machine alarmed with an air detector alarm.The blood clot was visually observed within the venous chamber of the combiset.The estimated blood loss (ebl) for the treatment due to the clotting was 300ml.The patient¿s hemoglobin was checked and resulted within normal limits (value not provided); however, the hdrn stated the hemoglobin would drop.Subsequently, the patient had two blood transfusions scheduled and were completed the following week.
 
Event Description
A hemodialysis registered nurse (hdrn) reported to fresenius this patient experienced blood clotting inside the venous chamber of the combiset.The hdrn stated that the patient completed the scheduled hd treatment on the fresenius 2008t machine with a fresenius dialyzer when the blood had clotted inside the venous chamber of the combiset.The 2008t machine alarmed with an air detector alarm.The blood clot was visually observed within the venous chamber of the combiset.The estimated blood loss (ebl) for the treatment due to the clotting was 300ml.The patient¿s hemoglobin was checked and resulted within normal limits (value not provided); however, the hdrn stated the hemoglobin would drop.Subsequently, the patient had two blood transfusions scheduled and were completed the following week.
 
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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
MDR Report Key11638851
MDR Text Key252941142
Report Number8030665-2021-00518
Device Sequence Number1
Product Code FJK
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,health
Type of Report Initial,Followup
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN- FMC BLOODLINE
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received04/13/2021
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 Outcome(s) Required Intervention;
Patient Age37 YR
Patient Weight69
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