MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET SMARTECH BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9C

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/21/2024

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¿s biomedical technician (bmt) reported that a combiset smartech bloodline leaked during a patient¿s hemodialysis (hd) treatment.The patient¿s estimated blood loss (ebl) is unknown.There was no patient injury, adverse event or medical intervention reported.The complaint device is available to be returned to the manufacturer for evaluation.At this time, no additional information has been provided.Should additional information become available, the file will be updated accordingly.

Event Description

A user facility¿s biomedical technician (bmt) reported that a combiset smartech bloodline leaked during a patient¿s hemodialysis (hd) treatment.Follow up with the facility administrator (fa) revealed that the leak occurred 15 minutes into the treatment from the blood pump segment of the bloodline.The machine, a fresenius 2008t hemodialysis machine, alarmed appropriately with an air detector alarm.A fresenius dialyzer was also in use.The patient¿s estimated blood loss (ebl) was 300ml.There was damage noted on the bloodline.There was no patient injury, adverse event or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.No issues were noted during priming and there were no changes in pressure during treatment.The complaint device is available to be returned to the manufacturer for evaluation.

Event Description

A user facility¿s biomedical technician (bmt) reported that a combiset smartech bloodline leaked during a patient¿s hemodialysis (hd) treatment.Follow up with the facility administrator (fa) revealed that the leak occurred 15 minutes into the treatment from the blood pump segment of the bloodline.The machine, a fresenius 2008t hemodialysis machine, alarmed appropriately with an air detector alarm.A fresenius dialyzer was also in use.The patient¿s estimated blood loss (ebl) was 300ml.There was damage noted on the bloodline.There was no patient injury, adverse event or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.No issues were noted during priming and there were no changes in pressure during treatment.The complaint device was not returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: 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.

• Brand Name: COMBISET SMARTECH 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; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18846602
• MDR Text Key: 337068623
• Report Number: 0008030665-2024-00244
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 23PR01148
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T HEMODIALYSIS MACHINE; FRESENIUS 2008T HEMODIALYSIS MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 113 KG