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

Catalog Number	03-2742-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/07/2024
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 facility administrator (fa) reported a blood leak at the arterial line from the red connector at the right side of the blood pump during a patient's hemodialysis (hd) treatment.The estimated blood loss was unknown.The sample was reportedly not available.Additional information was requested but was not received to date.
Additional 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 or Problem Description
A user facility administrator (fa) reported a blood leak at the arterial line from the red connector at the right side of the blood pump during a patient's hemodialysis (hd) treatment.Upon follow-up, the fa stated a combi set blood leak occurred on the arterial line on the red connection right side of the pump several seconds after initiation of the patient¿s hemodialysis (hd) treatment.The machine did not alarm with a blood leak alert.A fresenius 2008t machine and fresenius dialyzer were being utilized for the treatment.No visible damage was identified on the combi set prior to use.Immediately following the event, the patient was placed on a different machine and a new dialyzer and combi set were re-strung, and the patient began completed treatment without further issue.The machine was serviced and placed back in service.The patient¿s estimated blood loss (ebl) was unknown.The patient it was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The bmt stated the used combi set was not available to be returned for evaluation.
Event or Problem Description
A user facility facility administrator (fa) reported a blood leak at the arterial line from the red connector at the right side of the blood pump during a patient's hemodialysis (hd) treatment.Upon follow-up, the fa stated a combi set blood leak occurred on the arterial line on the red connection right side of the pump several seconds after initiation of the patient¿s hemodialysis (hd) treatment.The machine did not alarm with a blood leak alert.A fresenius 2008t machine and fresenius dialyzer were being utilized for the treatment.No visible damage was identified on the combi set prior to use.Immediately following the event, the patient was placed on a different machine and a new dialyzer and combi set were re-strung, and the patient began completed treatment without further issue.The machine was serviced and placed back in service.The patient¿s estimated blood loss (ebl) was unknown.The patient it was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The bmt stated the used combi set was not available to be returned for evaluation.
Additional Manufacturer Narrative
Additional information:, h3 plant investigation: reynosa received 1 case of companion samples on 06/07/2024 for evaluation, the sample was received with original package, identified with product code number 03-2742-9 and lot number 24ar01101.The companion product samples were visually inspected according to bom 03-2742-9, during the visual inspection it was not found any problems, no damages in the lines nor the chambers were observed.The sets were in the expected condition.A functional test was performed to the companion product samples in the 2008k machine and no disconnection or leaks occurred during tested period from the tubing.No air bubbles inside the system were noticed, no leaks, no level variation of venous and arterial chamber or any alarm.The sample tested worked as intended without any abnormalities during the tested period.A review of the dhr did not reveal a probable cause for the customer complaint.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 administrator (fa) reported a blood leak at the arterial line from the red connector at the right side of the blood pump during a patient's hemodialysis (hd) treatment.Upon follow-up, the fa stated a combi set blood leak occurred on the arterial line on the red connection right side of the pump several seconds after initiation of the patient¿s hemodialysis (hd) treatment.The machine did not alarm with a blood leak alert.A fresenius 2008t machine and fresenius dialyzer were being utilized for the treatment.No visible damage was identified on the combi set prior to use.Immediately following the event, the patient was placed on a different machine and a new dialyzer and combi set were re-strung, and the patient began completed treatment without further issue.The machine was serviced and placed back in service.The patient¿s estimated blood loss (ebl) was unknown.The patient it was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The bmt stated the used combi set was not available to be returned for evaluation.

• Brand Name: CUSTOM 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: 18896334
• Report Number: 0008030665-2024-00266
• Device Sequence Number: 7589035
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/21/2024

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: Health Professional
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 24AR01101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 03/15/2024; 04/03/2024; 11/21/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 03/15/2024; 04/10/2024; 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 52 KG