MAUDE Adverse Event Report: NOVAMED (ANTALYA) MULTIFILTRATEPRO SECUCAS CI-CA HD; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 36-8116-0

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

Patient Problems Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

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 a premature clotting occurred on an unknown date during a patient's continuous renal replacement therapy (crrt).The patient was utilizing an ultraflux av 1000 s dialyzer and a multifiltratepro secucas ci-ca hd cassette.The patient's estimated blood loss (ebl) was 200 ml or less and their treatment was discontinued.A sample was not available to be returned for evaluation.Despite multiple efforts to obtain additional information, no further details have been provided.

Event Description

Additional information was provided by a product manager who was in contact with the user facility.The anticoagulation regime was a standard value with 4.0 mmol/l.It was confirmed that several machines were involved.Comorbidities could not be provided.There was no medical intervention.Treatment was continued with a new system after the blood loss occurred.It was unknown if both products (the filter and the tubing) were affected by the clotting in each case.It was unknown if alarms occurred.Heparin was not used for any of the treatments; only citrate was used.Catheter information was unknown.The patient was ¿usually¿ set up again on the same device.The ports used were not needle-free ports.It was reported that blood is routinely taken via artery.There were no commonalities among the patients.Only the withdrawal port was used for ¿post filter calcium¿, the other needle-free ports were not used.The same kits were used when mounting the machines; they only use the cica set.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information: h6 (medical device problem code) plant investigation: the actual sample was not available for evaluation, and the lot number was not provided.As such, a device history record (dhr) review was performed on all possible batches.The results of the batch production record controls were found to be conforming.No non-conformities were observed during the manufacturing process.Although the actual sample was not available, an evaluation of the retained samples was performed by the manufacturer.The samples underwent a visual inspection where they were checked for component defects, assembly failures, and conformity with the product specifications.The samples then underwent leakage testing where they were checked under air/liquid pressure for leaks and other assembly failures.No failures were detected.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.Without examination of the actual complaint sample, a cause for the reported event could not be determined.

Event Description

Additional information was provided by a product manager who was in contact with the user facility.The anticoagulation regime was a standard value with 4.0 mmol/l.It was confirmed that several machines were involved.Comorbidities could not be provided.There was no medical intervention.Treatment was continued with a new system after the blood loss occurred.It was unknown if both products (the filter and the tubing) were affected by the clotting in each case.It was unknown if alarms occurred.Heparin was not used for any of the treatments; only citrate was used.Catheter information was unknown.The patient was ¿usually¿ set up again on the same device.The ports used were not needle-free ports.It was reported that blood is routinely taken via artery.There were no commonalities among the patients.Only the withdrawal port was used for ¿postfiltercalcium¿, the other needle-free ports were not used.The same kits were used when mounting the machines; they only use the cica set.No additional information was provided.

• Brand Name: MULTIFILTRATEPRO SECUCAS CI-CA HD
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): NOVAMED (ANTALYA); antalya freezone ctr branch; liman s b mah.4. sk.no:16; konyaalti-antalya 07070 ; TU 07070
• Manufacturer (Section G): NOVAMED (ANTALYA); antalya freezone ctr branch; liman s b mah.4. sk.no:16; konyaalti-antalya 07070 ; TU 07070
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16676443
• MDR Text Key: 312640027
• Report Number: 0001225714-2023-00014
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EUA200149
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 36-8116-0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/11/2023
• 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: ULTRAFLUX AV 1000 S; ULTRAFLUX AV 1000 S; ULTRAFLUX AV 1000 S