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 03-2722-9

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/21/2023

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility biomedical technician (bmt) stated two cases of combiset tubing lines had two cuts on the packages by the word vent.The bmt stated the facility used the line and the machine prompted with an air detector alarm.The line was replaced and started leaking blood.Upon follow-up, the bmt stated during priming of the machine, the machine prompted with an air detector alarm.The combiset was removed and the staff noticed a crack in the tubing line around where the tubing was placed into the blood pump rotor.A leak was not noted from the crack during priming.The staff then re-setup with another comibset from the same lot.During the patient¿s treatment after an unknown duration of time, a blood leak was observed from a similar crack along the tubing line at the blood pump segment of the tubing.The machine, a 2008t, alarmed with an air detector alarm and the machine was not removed from service following the event.A fresenius dialyzer was being used during the incident.Blood test strips were not required or used.Per bmt the patient's blood was reinfused, but a minimal amount of blood leaked had from the tubing line.The estimated blood loss (ebl) was unknown.The bmt 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 staff re-setup new supplies and a new combiset bloodlines from a different lot and the patient completed treatment on the same machine without further issue.The bmt stated no damage was noted with the packaging or combisets prior to use, and was unable to determine what may have caused the cracks and leaks in the tubing lines.The bmt stated the hemodialysis machine was evaluated and no issues were noted with the machine or blood pump rotor.The combi sets were discarded and were no longer available to be returned for evaluation.

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 Description

A user facility biomedical technician (bmt) stated two cases of combiset tubing lines had two cuts on the packages by the word vent.The bmt stated the facility used the line and the machine prompted with an air detector alarm.The line was replaced and started leaking blood.Upon follow-up, the bmt stated during priming of the machine, the machine prompted with an air detector alarm.The combiset was removed and the staff noticed a crack in the tubing line around where the tubing was placed into the blood pump rotor.A leak was not noted from the crack during priming.The staff then re-setup with another comibset from the same lot.During the patient¿s treatment after an unknown duration of time, a blood leak was observed from a similar crack along the tubing line at the blood pump segment of the tubing.The machine, a 2008t, alarmed with an air detector alarm and the machine was not removed from service following the event.A fresenius dialyzer was being used during the incident.Blood test strips were not required or used.Per bmt the patient's blood was reinfused, but a minimal amount of blood leaked had from the tubing line.The estimated blood loss (ebl) was unknown.The bmt 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 staff re-setup new supplies and a new combiset bloodlines from a different lot and the patient completed treatment on the same machine without further issue.The bmt stated no damage was noted with the packaging or combisets prior to use, and was unable to determine what may have caused the cracks and leaks in the tubing lines.The bmt stated the hemodialysis machine was evaluated and no issues were noted with the machine or blood pump rotor.The combi sets were discarded and were no longer available to be returned for evaluation.

• Brand Name: CUSTOM COMBI SET
• 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: 18222427
• MDR Text Key: 329245862
• Report Number: 0008030665-2023-01092
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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: Other
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 23JR01091
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 11/21/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2023
• 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 DIALYZER; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE