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

Model Number	03-2742-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A facility administrator (fa) reported to fresenius that the combiset bloodlines began leaking during a patient's hemodialysis (hd) treatment.Blood spurt from a split or hole in the tubing that was located near the blood pump.Additional information was provided by a facility clinical social worker.The reported event was discovered approximately one hour into treatment when the fresenius 2008t machine alarmed.The biomedical technician (biomed) was present at the facility and went to respond to the alarm when a pool of blood was observed at the base of the machine.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) could not be provided.The patient was transferred to a new machine where treatment completed successfully with new supplies.The clinical social worker confirmed that a "knick" was observed in the lines following the reported event.No issues were identified with the bloodlines during prime (with saline).The sample is available to be returned to the manufacturer for physical evaluation.The machine was pulled from service for evaluation by the biomed.The machine was thoroughly inspected and no issues were found.The machine passed functional testing and was returned to service.
Event or Problem Description
A facility administrator (fa) reported to fresenius that the combiset bloodlines began leaking during a patient's hemodialysis (hd) treatment.Blood spurt from a split or hole in the tubing that was located near the blood pump.Additional information was provided by a facility clinical social worker.The reported event was discovered approximately one hour into treatment when the fresenius 2008t machine alarmed.The biomedical technician (biomed) was present at the facility and went to respond to the alarm when a pool of blood was observed at the base of the machine.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) could not be provided.The patient was transferred to a new machine where treatment completed successfully with new supplies.The clinical social worker confirmed that a "knick" was observed in the lines following the reported event.No issues were identified with the bloodlines during prime (with saline).The sample is available to be returned to the manufacturer for physical evaluation.The machine was pulled from service for evaluation by the biomed.The machine was thoroughly inspected and no issues were found.The machine passed functional testing and was returned to service.
Additional Manufacturer Narrative
H3 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.

• 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: 16564739
• Report Number: 0008030665-2023-00287
• Device Sequence Number: 5691088
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 03/30/2023

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 Expiration Date: 10/31/2025
• Device Model Number: 03-2742-9
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 22NR01176
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• 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 DIALYZER; FRESENIUS DIALYZER
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 124 KG