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

Catalog Number UNKNOWN- FMC BLOODLINE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/23/2024

Event Type  malfunction  

Event Description

A user facility clinic manager (cm) reported to fresenius that a blood leak occurred with the fresenius dialyzer and bloodline set during the patient's hemodialysis (hd) treatment.The reported issue occurred 26 minutes after treatment initiation.The registered nurse (rn) visually observed blood leaking at the connection between the bloodline set and the venous side of the dialyzer.The rn attempted to tighten the connection but the leak continued.The 2008t machine was re-primed with new supplies to resolve the reported issue.Additional information was obtained during follow-up.There was no defect or damage noted to either product.No issues were encountered during prime.There was no serious injury or required medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) could not be provided.Treatment was restarted and successfully completed on the same machine with new supplies.The samples are available to be retuned 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. .

Event Description

A user facility clinic manager (cm) reported to fresenius that a blood leak occurred with the fresenius dialyzer and bloodline set during the patient's hemodialysis (hd) treatment.The reported issue occurred 26 minutes after treatment initiation.The registered nurse (rn) visually observed blood leaking at the connection between the bloodline set and the venous side of the dialyzer.The rn attempted to tighten the connection but the leak continued.The 2008t machine was re-primed with new supplies to resolve the reported issue.Additional information was obtained during follow-up.There was no defect or damage noted to either product.No issues were encountered during prime.There was no serious injury or required medical intervention as a result of the reported issue.The patient's estimated blood loss (ebl) could not be provided.Treatment was restarted and successfully completed on the same machine with new supplies.The samples are available to be retuned to the manufacturer for physical evaluation.

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.

• Brand Name: FMC BLOODLINE
• 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: 19023267
• MDR Text Key: 339245771
• Report Number: 0008030665-2024-00320
• Device Sequence Number: 1
• Product Code: FJK
• 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: Consumer,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- FMC BLOODLINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 56 KG