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 12/07/2023

Event Type  malfunction  

Event Description

A corporate inventory manager reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow-up with a registered nurse (rn) from the facility who was present at the time of the event.Per the rn, approximately one hour into the hd treatment, blood was seen dripping externally from the venous end of the dialyzer where the custom combi set was connected.There were no obvious defects noted at the connection point, and the rn confirmed that the bloodline seemed to be securely connected to the dialyzer.There were no alarms from the machine, a fresenius 2008t machine.It was confirmed that there was no leaking noticed during the priming phase.Once the blood leak was noticed, the treatment was stopped.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The patient was re-setup with new supplies on a different machine where they were able to complete the treatment.The rn 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 bloodlines were not available to be returned for evaluation as they were reportedly discarded.

Manufacturer Narrative

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

Event Description

A corporate inventory manager reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user facility.Additional information was obtained through follow-up with a registered nurse (rn) from the facility who was present at the time of the event.Per the rn, approximately one hour into the hd treatment, blood was seen dripping externally from the venous end of the dialyzer where the custom combi set was connected.There were no obvious defects noted at the connection point, and the rn confirmed that the bloodline seemed to be securely connected to the dialyzer.There were no alarms from the machine, a fresenius 2008t machine.It was confirmed that there was no leaking noticed during the priming phase.Once the blood leak was noticed, the treatment was stopped.The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml.The patient was re-setup with new supplies on a different machine where they were able to complete the treatment.The rn 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 bloodlines were not available to be returned for evaluation as they were reportedly discarded.

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 facility for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combi set 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: 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: 18422379
• MDR Text Key: 331684138
• Report Number: 0008030665-2023-01191
• 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: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/31/2024
• 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 OPTIFLUX DIALYZER; FRESENIUS OPTIFLUX DIALYZER
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 83 KG