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 Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/22/2023

Event Type  malfunction  

Manufacturer Narrative

Please see related mfr report #: 8030665-2024-00046, which has also been submitted.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

It was reported that multiple combi sets from this lot were clotting in the arterial chamber within minutes of initiating hemodialysis (hd) treatment.It was also reported that air bubbles were noted in the arterial chamber.It is unknown how much blood loss occurred due to the clotting.However, there was no reported patient injury or harm due to the events.It could not be confirmed if a sample was available to be sent back for evaluation.Multiple attempts were made to obtain additional information without success.

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

It was reported that multiple combi sets from this lot were clotting in the arterial chamber within minutes of initiating hemodialysis (hd) treatment.It was also reported that air bubbles were noted in the arterial chamber.It is unknown how much blood loss occurred due to the clotting.However, there was no reported patient injury or harm due to the events.It could not be confirmed if a sample was available to be sent back for evaluation.Multiple attempts were made to obtain additional information without success.

• 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: 18508647
• MDR Text Key: 333449463
• Report Number: 0008030665-2024-00045
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 23LR01207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2023
• 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