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 12/02/2023

Event Type  malfunction  

Event Description

A user facility charge nurse reported to fresenius that a hole was discovered in the venous portion of the combiset smartech bloodlines during a patient's hemodialysis (hd) treatment.The hole was approximately 1 centimeter (cm) wide.Blood was visually observed leaking from it.Additional information was obtained during follow-up with the charge nurse.The reported issue was discovered approximately 10 minutes after treatment initiation.The issue was discovered when the blood leak was visually observed.It was confirmed that the leak was located on the venous line before the venous chamber and a hole was identified measuring approximately 1 cm wide.There was no serious injury to the patient nor was medical intervention required.The patient's blood was not returned.The patient's estimated blood loss (ebl) is approximately 250 ml.The patient's vitals were stable upon disconnect.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint sample was reported to be discarded and unavailable to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Manufacturer Narrative

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.

Event Description

A user facility charge nurse reported to fresenius that a hole was discovered in the venous portion of the combiset smartech bloodlines during a patient's hemodialysis (hd) treatment.The hole was approximately 1 centimeter (cm) wide.Blood was visually observed leaking from it.Additional information was obtained during follow-up with the charge nurse.The reported issue was discovered approximately 10 minutes after treatment initiation.The issue was discovered when the blood leak was visually observed.It was confirmed that the leak was located on the venous line before the venous chamber and a hole was identified measuring approximately 1 cm wide.There was no serious injury to the patient nor was medical intervention required.The patient's blood was not returned.The patient's estimated blood loss (ebl) is approximately 250 ml.The patient's vitals were stable upon disconnect.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint sample was reported to be discarded and unavailable to be returned to the manufacturer for physical evaluation.

• 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: 18266384
• MDR Text Key: 329725478
• Report Number: 0008030665-2023-01107
• Device Sequence Number: 1
• Product Code: FJK
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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 Number: 03-2722-9C
• Device Lot Number: 23DR01128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/02/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2023
• 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 MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 83 YR
• Patient Sex: Male