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 10/26/2023

Event Type  malfunction  

Event Description

It was reported that at the time of the event, the patient had been sedated and in the hospital for nine days following septic shock post transplant.The patient had been on dialysis for three days when the circuit was changed on the morning of october 26, 2023.On the night of october 25, 2023, to october 26, 2023 during the patient¿s continuous venovenous hemodialysis (cvvhd) treatment a significant and intense increase in venous pressure occurred and the generator triggered an alarm.An unidentified body was observed at the end of the venous tube, blocking the flow.It was impossible to return the patient¿s blood which resulted in approximately 300 ml of blood loss.After the reported event, dialysis was stopped for the patient, but this was unrelated the event.The sample was reported to not be available 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 sample was not returned.Batch production record controls resulted with conformity.Nonconformity was not observed during manufacturing process.Complaint history review confirmed there was no other complaint reported for the batch.The reported event is adequately addressed in the instructions for use and/or the label.There is no indication that the reported failure relates to falsification.The retained samples evaluation confirmed there was no failure detected.According to the results of the production group investigation, no change was observed to the production or manufacturing processes.The possible reason of the defect is related to inadequate product design.

Event Description

It was reported that at the time of the event, the patient had been sedated and in the hospital for nine days following septic shock post transplant.The patient had been on dialysis for three days when the circuit was changed on the morning of (b)(6) 2023.On the night of (b)(6) 2023, to (b)(6) 2023 during the patient¿s continuous venovenous hemodialysis (cvvhd) treatment a significant and intense increase in venous pressure occurred and the generator triggered an alarm.An unidentified body was observed at the end of the venous tube, blocking the flow.It was impossible to return the patient¿s blood which resulted in approximately 300 ml of blood loss.After the reported event, dialysis was stopped for the patient, but this was unrelated the event.The sample was reported to not be available 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: 18237714
• MDR Text Key: 329374126
• Report Number: 3002807005-2023-00049
• 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,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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: 11/13/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/16/2024
• 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: MULTIFILTRATEPRO SECUCAS CI-CA HD
• Patient Age: 57 YR
• Patient Sex: Female