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 combi set bloodline leaked during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with the registered nurse (rn).She said that 5 minutes in to the patient¿s treatment, the machine, a fresenius 2008t hemodialysis machine, alarmed for ¿air detected¿.A fresenius optiflux 180nre dialyzer was also in use.The external leak was visually observed from the bloodline tubing before the blood pump segment.There was no changes to the blood flow rate or disruption in pressure during the treatment.There were no issues noted during prime.There was no visible damage to the bloodline.The patient¿s estimated blood loss (ebl) was approximately 300 ml.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.The complaint device is available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.As the complaint product sample was being disinfected and prepared for analysis, a leak was found on the pump tubing.The complaint product sample was visually inspected.During the visual inspection it was found that the pump tubing had a tear causing a leak.After further inspection, no other problems were found.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.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.Upon completion of the evaluation, the reported event was confirmed.

Event Description

A user facility¿s biomedical technician (bmt) reported that a combi set bloodline leaked during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with the registered nurse (rn).She said that 5 minutes in to the patient¿s treatment, the machine, a fresenius 2008t hemodialysis machine, alarmed for ¿air detected¿.A fresenius optiflux 180nre dialyzer was also in use.The external leak was visually observed from the bloodline tubing before the blood pump segment.There was no changes to the blood flow rate or disruption in pressure during the treatment.There were no issues noted during prime.There was no visible damage to the bloodline.The patient¿s estimated blood loss (ebl) was approximately 300 ml.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.The complaint device is available to be returned to the manufacturer for 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: 18769530
• MDR Text Key: 337068704
• Report Number: 0008030665-2024-00206
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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: 23PR01143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• 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 OPTIFLUX 180NRE DIALYZER.; FRESENIUS OPTIFLUX 180NRE DIALYZER.
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 113 KG