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	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility clinic manager (cm) reported to fresenius that the injection port on the saline line of the combiset bloodlines leaked during a patient's hemodialysis (hd) treatment resulting in air in the circuit.The patient's blood was not returned.Additional information was obtained during follow-up with the cm and a user facility registered nurse (rn).The rn stated the reported issue occurred approximately 30-45 days prior to initial reporting.The rn stated that within the first hour of treatment that blood was visually observed dripping.The 2008t machine alarmed with an air detector message.The rn stated that air was sucked into the injection and backflowing out of saline line.The rn stated that the arterial side had filled with air.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was not provided.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient completed treatment on the same machine with new supplies.The bloodline set was discarded and is not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the customer for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr 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 clinic manager (cm) reported to fresenius that the injection port on the saline line of the combiset bloodlines leaked during a patient's hemodialysis (hd) treatment resulting in air in the circuit.The patient's blood was not returned.Additional information was obtained during follow-up with the cm and a user facility registered nurse (rn).The rn stated the reported issue occurred approximately 30-45 days prior to initial reporting.The rn stated that within the first hour of treatment that blood was visually observed dripping.The 2008t machine alarmed with an air detector message.The rn stated that air was sucked into the injection and backflowing out of saline line.The rn stated that the arterial side had filled with air.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was not provided.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient completed treatment on the same machine with new supplies.The bloodline set was discarded and is not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

• 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: 18527497
• Report Number: 0008030665-2024-00059
• Device Sequence Number: 15350082
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 BLOODLINES; FRESENIUS BLOODLINES
• Patient Sex: Male