MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH FX CORAL FX80 HF 24/CS 1.8SA STEAM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number F00009217

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/13/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A nurse from a user facility reported that a dialyzer blood leak occurred during a patient¿s post-dilution hemodiafiltration (hdf) therapy.The leak occurred two hours into the patient¿s treatment.The machine responded appropriately and an alarm was triggered once the blood leak started.The patient suffered no consequences and their treatment was finished on another device.The patient¿s estimated blood loss (ebl) was 50 ml or less.The sample was not available to be returned for evaluation.

Manufacturer Narrative

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

Event Description

Upon follow-up, it was reported that the leak actually occurred two hours and forty-five minutes into the patient¿s treatment.The blood leak was reported to be internal ¿ there was presence of blood in the dialysate return connector.The blood leak was confirmed to be visually observed as the dialysate was notably pink.There were no visible defects on the dialyzer.The machine, a fresenius 5008, did alarm appropriately with a blood leak alarm.There were no other types of alarms from the machine.Fresenius bloodlines were also being used.A blood test strip was not used.It was confirmed there was no patient injury, adverse event, or medical intervention required due to the blood loss.A nurse from the user facility documented that there were ¿a lot of clots in the bubble trap¿, and it was questioned whether there was also coagulation in the filter.The patient was re-setup with new supplies on a different machine with the same configurations as at the start of dialysis.

Event Description

Upon follow-up, it was reported that the leak actually occurred two hours and forty-five minutes into the patient¿s treatment.The blood leak was reported to be internal ¿ there was presence of blood in the dialysate return connector.The blood leak was confirmed to be visually observed as the dialysate was notably pink.There were no visible defects on the dialyzer.The machine, a fresenius 5008, did alarm appropriately with a blood leak alarm.There were no other types of alarms from the machine.Fresenius bloodlines were also being used.A blood test strip was not used.It was confirmed there was no patient injury, adverse event, or medical intervention required due to the blood loss.A nurse from the user facility documented that there were ¿a lot of clots in the bubble trap¿, and it was questioned whether there was also coagulation in the filter.The patient was re-setup with new supplies on a different machine with the same configurations as at the start of dialysis.

Manufacturer Narrative

Plant investigation: the complaint sample was not available for evaluation and no meaningful pictures were provided.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, a retention sample analysis was not done.Although the 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 investigation was performed.28,896 products were inspected according to the inspection protocol and were found to be conforming to specifications.The review found no indications of a relationship with the reported failure mode.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.

• Brand Name: FX CORAL FX80 HF 24/CS 1.8SA STEAM
• 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: 18671513
• MDR Text Key: 334924962
• Report Number: 3002807005-2024-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K220721
• 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,Followup,Followup
• Report Date: 03/06/2024

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: F00009217
• Device Lot Number: E4FH21100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 02/15/2024; 02/14/2024
• Supplement Dates FDA Received: 02/16/2024; 03/06/2024
• 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: FRESENIUS 5008 MACHINE; FRESENIUS 5008 MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG