MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH ULTRAFLUX AV 600 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 5007361

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/19/2022

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 that an internal dialyzer blood leak occurred fifty minutes after the start of a patient¿s continuous renal replacement therapy (crrt).The machine, a multifiltrate system, alarmed appropriately with a blood leak alert.The blood leak was confirmed to be visually observed in the dialyzer.There was no visible damage observed on the dialyzer.There was no reported leaking during the priming.Following the blood leak, the treatment was immediately paused.The patient¿s estimated blood loss (ebl) was less than 50 ml.The patient completed treatment after being re-setup with new supplies on the same machine.The event delayed the patient¿s treatment by thirty minutes.However, the blood loss did not result in any patient injury or harm, and the patient did not require medical intervention.The sample was not available to be returned for manufacturer evaluation.

Manufacturer Narrative

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.

Event Description

It was reported that an internal dialyzer blood leak occurred fifty minutes after the start of a patient¿s continuous renal replacement therapy (crrt).The machine, a multifiltrate system, alarmed appropriately with a blood leak alert.The blood leak was confirmed to be visually observed in the dialyzer.There was no visible damage observed on the dialyzer.There was no reported leaking during the priming.Following the blood leak, the treatment was immediately paused.The patient¿s estimated blood loss (ebl) was less than 50 ml.The patient completed treatment after being re-setup with new supplies on the same machine.The event delayed the patient¿s treatment by thirty minutes.However, the blood loss did not result in any patient injury or harm, and the patient did not require medical intervention.The sample was not available to be returned for manufacturer evaluation.

• Brand Name: ULTRAFLUX AV 600 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH; st. wendel plant; frankfurter strabe 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15665185
• MDR Text Key: 306279888
• Report Number: 3002807005-2022-00030
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5007361
• Device Lot Number: C1BM07100
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/05/2023
• 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: MULTIFILTRATE MACHINE; MULTIFILTRATE MACHINE
• Patient Sex: Female