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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 01/01/2024

Event Type  Death  

Event Description

On 6/feb/2024, fresenius became aware this patient with an acute kidney injury (aki) was undergoing continuous veno-venous hemodialysis (cvvhd) utilizing a multifiltrate pro secure cassette for renal replacement therapy (rrt) experienced an in-hospital cardiac arrest (ihca) on (b)(6) 2024.The complaint record revealed the patient was admitted (initial admission date not provided) to the intensive care unit (icu) on (b)(6) 2024 after suffering an ihca (cause not provided).The patient was initially hospitalized due to acute/chronic renal insufficiency following a kidney transplant.While in the icu the patient developed an acute kidney injury (aki) and was treated with ci-ca cvvhd utilizing a multifiltrate pro secure cassette with ci-ca plus dialysate.After approximately 42 hours of treatment, white stripes were visible in the calcium replacement line.The treatment was stopped, and the patient¿s blood was returned.The patient¿s fibrinogen build-up was determined to be 8.3 g/l and a new cvvhd treatment was started using the same multifiltrate pro secure cassette with ci-ca dialysate without phosphate.After changing the dialysate composition, no more white streaks were noted.It was determined the cause of the white striping was the phosphate contained in the ci-ca plus dialysate in combination with the patient¿s high fibrinogen level and the replacement calcium through the return line.Despite the white streaking occurring during treatment, there was no evidence a serious adverse event occurred due to the stoppage of treatment.Although the timeline of events is largely unknown, it was reported the patient expired (date not provided) due to a poor prognosis following the ihca.It is unknown if the patient was receiving cvvhd when he expired.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: t is unknown if a temporal relationship exists between cvvhd utilizing the multifiltrate pro secure cassette, and the patients¿ serious adverse event of death.The patient¿s cause of death is unknown; therefore, causality could not firmly be established.Limited follow-up information regarding the timeline of events, and the patient¿s hospital course prevented a more comprehensive investigation.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Of these deaths, cardiovascular disease (or sudden cardiac death) accounts for the most deaths among the esrd population.Of note: after changing the dialysate composition (ci-ca dialysate without phosphate), no more white streaks were noted.It was determined the cause of the white striping was the phosphate contained in the ci-ca plus dialysate, in combination with the patient¿s high fibrinogen level and the replacement calcium through the return line.Despite the white streaking occurring during treatment, the patient¿s blood was returned, and there was no evidence a serious adverse event(s) occurred due to the stoppage of treatment.Based on the totality of the information available, the multifiltrate pro secure cassette can be disassociated from the serious adverse event of death.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused and/or contributed to the serious adverse events.Furthermore, there was no report or documentation provided which indicated a fresenius device(s) and/or product(s) failed to meet the users¿ expectations and/or the manufacturers¿ specifications.

Manufacturer Narrative

Additional information provided in b5.Upon further review of this file, it was determined the event details do not meet reporting criteria.Therefore, mdr with mfr 225714-2024-00014 will have no further updates.

Event Description

Additional information received states the patient did not have blood loss or medical intervention due to the reported white stripes visible in the calcium replacement line.Additionally, the patient death occurred two days after the reported event due to a cardiac event unrelated to the reported product and event.

• 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: 18783027
• MDR Text Key: 336269151
• Report Number: 0001225714-2024-00014
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 36-8116-0
• Device Lot Number: E9UF151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/07/2024
• 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
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Weight: 121 KG