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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/26/2023

Event Type  Injury  

Manufacturer Narrative

A2: the patient's birthyear was provided without disclosing the full date of birth.As a result the patient's date of birth has been reported as on (b)(6) 1987.Clinical investigation: a temporal relationship exists between cvvhd utilizing the ultraflux emic2 filter, and the serious adverse event of dic.The patient was admitted for a paracetamol overdose (characterized by alf, deranged clotting, increased dextrose requirement, and shock) and was being treated with cvvhd when the dic began.Given the patient¿s positive response to the discontinuation of therapy (resolution of dic), the documentation provided indicates the ultraflux emic2 was cited as the potential cause of the serious adverse event.Therefore, based on the totality of the information available, the ultraflux emic2 cannot be excluded from having a possible causal or contributory role in the patient¿s serious adverse event.Despite there being no observed / reported manufacturing defect(s); minimal access to the patient¿s hospital records, treatment records, or further evaluation of the suspect product(s), prevented this clinical investigation from disassociating the ultraflux emic2 from the serious adverse event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

On 26/jun/2023, fresenius became aware a patient with acute liver failure (alf) and acute kidney injury (aki) on continuous venovenus hemodialysis (cvvhd) in the intensive care unit (icu) experienced life threatening disseminated intravascular coagulation (dates not provided).Records revealed the patient presented to the hospital with alf, deranged clotting, increased dextrose requirement, and shock following a paracetamol overdose.Upon arrival to the icu, the patient was intubated and started on cvvhd (via a left intrajugular catheter, not a fresenius product), utilizing the ultraflux emic2 filter (anticoagulant free).The patient began showing signs of improvement, however on day 9 of cvvhd (no alarms present) the patient developed life threatening dic (from all line / catheter sites) with unrecordably low fibrinogen and platelets.The patient¿s d-dimer was 17,600 ng/ml and no anticoagulation was administered before or during the dic event.The dic lasted for approximately 8 days, requiring large volumes of fresh frozen plasma (ffp), fibrinogen concentrate, and platelets.The cause of dic could not be determined (no signs of sepsis, pancreatitis, or causative drug), and on day 13 the patient was removed from cvvhd.A plasma exchange was performed using centrifuge technology with ffp as a last resort for the treatment of dic, and the patient began to improve (i.E., shock resolved, falling ammonia level, normalization of coagulation profile, no longer required supplemental dextrose, alf improving).Therefore, cvvhd was not restarted and the cause of the dic was presumed to be the ultraflux emic2 filter.The reporting clinician indicates the hospitals¿ standard of care for treating patients with rhabdomyolysis, septicemia and alf was instituted, and included cvvhd utilizing hourly 4.8-liter volume exchanges, ultrafiltration = 100 ml / hour, and a blood flow rate of 250-350 ml.Additionally, the patient was receiving propofol, alfentanil, meropenem and anidulafungin (despite no positive micro/infection markers).The patient¿s current disposition is unknown.

Manufacturer Narrative

Correction: g2 (report source) plant investigation: the cause for the failure reported cannot be confirmed based on the current available information.The extraction of retained samples showed no unusual residuals which could lead to the reported situation.Additionally further unused samples of the complained batch were inspected according to the inspection protocol for sieving coefficient and were found conforming to release specifications.Therefore, it is assumed that the complained situation of the patient might be caused by other factors besides the suspected dialyzer, for example, the specific physical/medical status of patient or the long treatment without anticoagulation.Anticoagulation is addressed in the instructions for use (ifu) and monitoring for it is recommended.A device history record (dhr) review was performed.The batch records were reviewed.7620 products have been inspected according to the inspection 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

On (b)(6) 2023, fresenius became aware a patient with acute liver failure (alf) and acute kidney injury (aki) on continuous venovenus hemodialysis (cvvhd) in the intensive care unit (icu) experienced life threatening disseminated intravascular coagulation (dates not provided).Records revealed the patient presented to the hospital with alf, deranged clotting, increased dextrose requirement, and shock following a paracetamol overdose.Upon arrival to the icu, the patient was intubated and started on cvvhd (via a left intrajugular catheter, not a fresenius product), utilizing the ultraflux emic2 filter (anticoagulant free).The patient began showing signs of improvement, however on day 9 of cvvhd (no alarms present) the patient developed life threatening dic (from all line/catheter sites) with unrecordably low fibrinogen and platelets.The patient¿s d-dimer was 17,600 ng/ml and no anticoagulation was administered before or during the dic event.The dic lasted for approximately 8 days, requiring large volumes of fresh frozen plasma (ffp), fibrinogen concentrate, and platelets.The cause of dic could not be determined (no signs of sepsis, pancreatitis, or causative drug), and on day 13 the patient was removed from cvvhd.A plasma exchange was performed using centrifuge technology with ffp as a last resort for the treatment of dic, and the patient began to improve (i.E., shock resolved, falling ammonia level, normalization of coagulation profile, no longer required supplemental dextrose, alf improving).Therefore, cvvhd was not restarted and the cause of the dic was presumed to be the ultraflux emic2 filter.The reporting clinician indicates the hospitals¿ standard of care for treating patients with rhabdomyolysis, septicemia and alf was instituted, and included cvvhd utilizing hourly 4.8-liter volume exchanges, ultrafiltration = 100 ml/hour, and a blood flow rate of 250-350 ml.Additionally, the patient was receiving propofol, alfentanil, meropenem and anidulafungin (despite no positive micro/infection markers).The patient¿s current disposition is unknown.

• 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: 17324806
• MDR Text Key: 319180553
• Report Number: 3002807005-2023-00031
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01-9771-0
• Device Lot Number: D2BC03100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/04/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 90 KG