MAUDE Adverse Event Report: ST. WENDEL AG ULTRAFLUX EMIC2; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 01-9771-0

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to fresenius that a dialyzer blood leak occurred during the patient's continuous renal replacement therapy (crrt) with the ultraflux dialyzer.The reported issue was observed upon treatment initiation.Dialysate was visually observed leaking from the head of the dialyzer.It was confirmed that no leakage was observed during prime.Treatment was discontinued.The patient was reinfused.The patient's estimated blood loss (ebl) is approximately 75 ml.No serious injury or required medical intervention was reported.Treatment was able to continue after the supplies were replaced.The sample was reported to be available to be returned to the manufacturer for physical evaluation.Additional information was requested however a response was not received.

• Brand Name: ULTRAFLUX EMIC2
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 18731267
• MDR Text Key: 335715770
• Report Number: 3002807005-2024-00005
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/19/2024

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: Health Professional
• Device Catalogue Number: 01-9771-0
• Device Lot Number: C2BL17100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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