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

Catalog Number	03-2622-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility technical assistant reported during hemodialysis (hd) treatment, an external leakage was noted through the heparin line.The staff immediately replaced the defective piece with new supplies in order to finish the treatment.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event as report at intake.Upon follow-up received, it was reported the blood leak occurred ten minutes after initiation of a patient's hemodialysis (hd) treatment.It was reported the heparin line detached and caused the blood leak.The unknown hd machine did not alarm with a blood leak alarm and blood leak test strips were not used.No damage and/or defects were noted.There was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment completed successfully with the bloodline replaced.The estimated blood loss (ebl) was 10ml.It was unknown if the patient's blood was returned.The sample was not available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.The complaint product sample was not provided for evaluation.However, a photo of the alleged malfunction was received from the customer.According with the photo received, it can be observed a separation on the heparin line from the assembly of the red "t" connector.With the photo received it cannot be observed the condition of the tubing and connector like the presence of solvent on the component.The alleged failure mode was confirmed; a separation was observed according with the photo received from the customer.A dhr review was performed for the involved lot of the product and there were no non-conformances, any associated rework related with the alleged failure mode during the assembly of the lot involved.All the applicable in-process and final inspection tests were found with acceptable results.Additionally, it was found that during the assembly process of this lot there was personal under training period.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 or Problem Description
A user facility technical assistant reported during hemodialysis (hd) treatment, an external leakage was noted through the heparin line.The staff immediately replaced the defective piece with new supplies in order to finish the treatment.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event as report at intake.Upon follow-up received, it was reported the blood leak occurred ten minutes after initiation of a patient's hemodialysis (hd) treatment.It was reported the heparin line detached and caused the blood leak.The unknown hd machine did not alarm with a blood leak alarm and blood leak test strips were not used.No damage and/or defects were noted.There was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment completed successfully with the bloodline replaced.The estimated blood loss (ebl) was 10ml.It was unknown if the patient's blood was returned.The sample was not available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.The complaint product sample was not provided for evaluation.However, a photo of the alleged malfunction was received from the customer.According with the photo received, it can be observed a separation on the heparin line from the assembly of the red "t" connector.With the photo received it cannot be observed the condition of the tubing and connector like the presence of solvent on the component.The alleged failure mode was confirmed; a separation was observed according with the photo received from the customer.A dhr review was performed for the involved lot of the product and there were no non-conformances, any associated rework related with the alleged failure mode during the assembly of the lot involved.All the applicable in-process and final inspection tests were found with acceptable results.Additionally, it was found that during the assembly process of this lot there was personal under training period.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.All the applicable in-process and final inspection tests were found with acceptable results.Additionally, it was found that during the assembly process of this lot there was personal under training period.
Event or Problem Description
A user facility technical assistant reported during hemodialysis (hd) treatment, an external leakage was noted through the heparin line.The staff immediately replaced the defective piece with new supplies in order to finish the treatment.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event as report at intake.Upon follow-up received, it was reported the blood leak occurred ten minutes after initiation of a patient's hemodialysis (hd) treatment.It was reported the heparin line detached and caused the blood leak.The unknown hd machine did not alarm with a blood leak alarm and blood leak test strips were not used.No damage and/or defects were noted.There was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment completed successfully with the bloodline replaced.The estimated blood loss (ebl) was 10ml.It was unknown if the patient's blood was returned.The sample was not available to be returned for manufacturer evaluation.

• Brand Name: COMBI SET
• Common Device Name: 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: 18117651
• Report Number: 0008030665-2023-01028
• Device Sequence Number: 20551607
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K962081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2024

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
• Operator of Device: Other
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 23ER01047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 02/08/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/17/2024; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 48 KG