MAUDE Adverse Event Report: ST. WENDEL AG ULTRAFLUX AV 1000 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 01-8981-0

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

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 an ultraflux dialyzer experienced a membrane rupture which resulted in a blood leak approximately 30 minutes after the initiation of the patient¿s continuous venovenous hemodiafiltration (cvvhdf) treatment.The blood leak was noted as being an internal blood leak.The leak was not visually observed.The machine, a fresenius multifiltrate (mtf) system, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test the presence of blood.There was no defect or damage noted on the dialyzer and no issues were noticed during prime.The patient¿s estimated blood loss (ebl) was approximately 20 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine where treatment completed successfully with new supplies.The complaint device was reported to be discarded and unavailable to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Correction: a3.

Event Description

It was reported to fresenius that an ultraflux dialyzer experienced a membrane rupture which resulted in a blood leak approximately 30 minutes after the initiation of the patient¿s continuous venovenous hemodiafiltration (cvvhdf) treatment.The blood leak was noted as being an internal blood leak.The leak was not visually observed.The machine, a fresenius multifiltrate (mtf) system, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test the presence of blood.There was no defect or damage noted on the dialyzer and no issues were noticed during prime.The patient¿s estimated blood loss (ebl) was approximately 20 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine where treatment completed successfully with new supplies.The complaint device was reported to be discarded and unavailable to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: the complaint sample was not available and no meaningful pictures were attached.Due to 100% testing, it is highly unlikely to detect a failure in the retention sample.Although our dialyzers are 100% tested for leaks (bubble-point and air testing during sterilization), leakages due to adverse environmental conditions or mechanical stress during treatment can occur in very few cases.A batch record review was performed and it was confirmed that products have been inspected according to protocol and were found conforming to specifications.No indication for any relationship with the reported failure mode has been found during the review.

Event Description

It was reported to fresenius that an ultraflux dialyzer experienced a membrane rupture which resulted in a blood leak approximately 30 minutes after the initiation of the patient¿s continuous venovenous hemodiafiltration (cvvhdf) treatment.The blood leak was noted as being an internal blood leak.The leak was not visually observed.The machine, a fresenius multifiltrate (mtf) system, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test the presence of blood.There was no defect or damage noted on the dialyzer and no issues were noticed during prime.The patient¿s estimated blood loss (ebl) was approximately 20 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine where treatment completed successfully with new supplies.The complaint device was reported to be discarded and unavailable to be returned to the manufacturer for evaluation.

Event Description

It was reported to fresenius that an ultraflux dialyzer experienced a membrane rupture which resulted in a blood leak approximately 30 minutes after the initiation of the patient¿s continuous venovenous hemodiafiltration (cvvhdf) treatment.The blood leak was noted as being an internal blood leak.The leak was not visually observed.The machine, a fresenius multifiltrate (mtf) system, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test the presence of blood.There was no defect or damage noted on the dialyzer and no issues were noticed during prime.The patient¿s estimated blood loss (ebl) was approximately 20 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine where treatment completed successfully with new supplies.The complaint device was reported to be discarded and unavailable to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Correction: h6 (investigation findings and investigation conclusions), h10 (expanded to include more information from plant investigation) plant investigation: the complaint sample was not available for evaluation and no meaningful pictures were provided.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.Due to 100% testing, it is highly unlikely to detect a failure in a retention sample.Furthermore, only a small number of reserve samples are available.Therefore, the retention sample analysis was not done.A review of the device history record (dhr) was performed.All released products were found to be conforming to specifications.The review found there was no indication that any relationship exists with the reported failure mode.Although all dialyzers are 100% tested for leaks (bubble-point and air testing during sterilization), leaks due to adverse environmental conditions or mechanical stress during treatment can occur in very few cases.

• Brand Name: ULTRAFLUX AV 1000 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ST. WENDEL AG; fmc deutschland gmbh; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; fmc deutschland gmbh; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14434095
• MDR Text Key: 300309499
• Report Number: 3002807005-2022-00013
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01-8981-0
• Device Lot Number: B2BA27100
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/06/2023
• 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 MULTIFILTRATE (MTF) SYSTEM.; FRESENIUS MULTIFILTRATE (MTF) SYSTEM.; FRESENIUS MULTIFILTRATE (MTF) SYSTEM.; FRESENIUS MULTIFILTRATE (MTF) SYSTEM.
• Patient Sex: Male