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 01/03/2024

Event Type  malfunction  

Event Description

It was reported that a dialyzer blood leak occurred during a patient¿s continuous renal replacement therapy (crrt).The dialysis machine alarmed with a presence of bubbles near the venous bubble trap alarm, however there were no visible bubbles.The patient was disconnected and the catheter secure.A white filament from the venous line was removed.The filament resembled a polymer that could possibly be a part of the dialysis kit membrane.The patient disconnection without restitution and treatment was reset up with another kit.Treatment was interrupted for one hour that resulted in approximately 200 ml of blood loss.The sample was not available to be returned for evaluation.Additional information requested but has not been obtained.

Manufacturer Narrative

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

Manufacturer Narrative

Investigation: the complaint sample was received for visual examination.Visual examination confirmed the reported failure.The reported event is adequately addressed in the instructions for use.It is manufactured under well controlled environmental conditions.The analysis of the foreign body showed that it is biological material and that it could not have been introduced during production.The device history record review indicated that there was no indication for any relationship with the reported failure mode has been found during review.Complaint history reviewed indicated that there is no other complaint regarding this lot.The reported event is covered in the risk analysis.

Event Description

It was reported that a dialyzer blood leak occurred during a patient¿s continuous renal replacement therapy (crrt).The dialysis machine alarmed with a presence of bubbles near the venous bubble trap alarm, however there were no visible bubbles.The patient was disconnected and the catheter secure.A white filament from the venous line was removed.The filament resembled a polymer that could possibly be a part of the dialysis kit membrane.The patient disconnection without restitution and treatment was reset up with another kit.Treatment was interrupted for one hour that resulted in approximately 200 ml of blood loss.The sample was not available to be returned for evaluation.Additional information requested but has not been obtained.

Manufacturer Narrative

Additional information provided in h6 and h10.Investigation: the complaint sample was received for visual examination.Visual examination did not confirm the reported failure.The reported event is adequately addressed in the instructions for use and/or on the label and the product deficiency is not related to falsification.The analysis of the foreign body showed that it is biological material and it is not a polymer.The white strips may be protein deposits caused by clogging.An insertion about production is to be excluded.It is manufactured under well controlled environmental conditions.Therefore, it is assumed that no foreign bodies are present and that any residues of the composition will not cause chemical/physical harm to the patient.The device history record review indicated that there was no indication for any relationship with the reported failure mode has been found during review.Complaint history reviewed indicated that there is one other complaint regarding this lot.The reported event is covered in the risk analysis.The reported event is not confirmed as the product functioned as intended.

Event Description

It was reported that a dialyzer blood leak occurred during a patient¿s continuous renal replacement therapy (crrt).The dialysis machine alarmed with a presence of bubbles near the venous bubble trap alarm, however there were no visible bubbles.The patient was disconnected and the catheter secure.A white filament from the venous line was removed.The filament resembled a polymer that could possibly be a part of the dialysis kit membrane.The patient disconnection without restitution and treatment was reset up with another kit.Treatment was interrupted for one hour that resulted in approximately 200 ml of blood loss.The sample was not available to be returned for evaluation.Additional information requested but has not been obtained.

• 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: 18573340
• MDR Text Key: 333624550
• Report Number: 3002807005-2024-00001
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

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: E2BA10100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 04/22/2024; 04/30/2024
• Supplement Dates FDA Received: 05/02/2024; 05/02/2024
• 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