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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/01/2024

Event Type  malfunction  

Event Description

A user facility clinic manager (cm) reported to fresenius that a blood leak occurred with the combiset trueflow series bloodlines during the patient's hemodialysis (hd) treatment.The blood leak occurred at the connection between the patient's central venous catheter (cvc) (not a fresenius product) and the bloodlines.The connection was not threading and securing properly.Blood was leaking from connection and the connection was "tightened aggressively" to resolve the issue.Additional information was obtained during follow-up.There was no serious injury or required medical intervention regarding the reported issue.The patient's estimated blood loss (ebl) was approximately 10 ml.Upon tightening the connection, treatment was restarted and successfully completed on the same machine with the same supplies.The sample was discarded and is not available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

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

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 clinic manager (cm) reported to fresenius that a blood leak occurred with the combiset trueflow series bloodlines during the patient's hemodialysis (hd) treatment.The blood leak occurred at the connection between the patient's central venous catheter (cvc) (not a fresenius product) and the bloodlines.The connection was not threading and securing properly.Blood was leaking from connection and the connection was "tightened aggressively" to resolve the issue.Additional information was obtained during follow-up.There was no serious injury or required medical intervention regarding the reported issue.The patient's estimated blood loss (ebl) was approximately 10 ml.Upon tightening the connection, treatment was restarted and successfully completed on the same machine with the same supplies.The sample was discarded and is not available to be returned to the manufacturer for physical 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: 18955528
• MDR Text Key: 338610980
• Report Number: 0008030665-2024-00291
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 24AR01101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2024
• 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 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.
• Patient Sex: Male