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 Problems Air Embolism (1697); Bradycardia (1751); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)

Event Date 03/07/2023

Event Type  Injury  

Event Description

It was reported that a patient with acute kidney injury (aki) on continuous renal replacement therapy (crrt) experienced a cardiopulmonary arrest following the discontinuation of treatment.The complaint documentation revealed the patient was hospitalized for the surgical removal of an aortic stent due to an ia endoleak (blood leakage at anastomosis site).Following the procedure, the patient required mechanical ventilation due to hemodynamic instability, in addition to septic shock, pneumopathy (lung infection), and aki.The patient was admitted to the intensive care unit (icu) and a temporary hemodialysis (hd) catheter (not a fresenius product) was placed for the purposes of crrt therapy.On (b)(6) 2023, at approximately 8:00 am (local time) the patient¿s crrt treatment was completed (without reported issue), and the patient¿s extracorporeal blood was reinfused.Following reinfusion, the patient became agitated, and it was discovered air (embolism) had entered the patient¿s body (at least 10 ml after aspiration) via the inlet line.Shortly after termination the patient became hypotensive (value not provided), bradycardic (heart rate = 40 bpm), lost consciousness, and subsequently experienced a cardiopulmonary arrest.Cardiopulmonary resuscitative (cpr) measures were implemented and after approximately 10 minutes the patient regained ¿circulatory activity¿ (specifics not provided).The patient was transferred to a hyperbaric chamber following the serious adverse events, and the patient¿s temporary hd catheter was removed and replaced with an internal jugular catheter (not a fresenius product) for further rrt.The patient¿s current disposition is unknown.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between crrt utilizing the multifiltrate pro secucas and the serious adverse events of aki, air embolism (characterized by hypotension and bradycardia), loss of consciousness, and cardiopulmonary arrest.The patient¿s completion of crrt and reinfusion was performed moments prior to the air embolism being discovered, thus making causality difficult to establish.However, it should be noted the patient was critically ill and hemodynamically compromised prior to the serious adverse events occurring.Air embolisms can occur before, during, and/or after crrt therapy is performed.Incorrect closure/tightening of access clamps, cassette clamps and/or luer lock connections can result in the delivery of an air embolism to the patient.Based on the totality of the information available, the multifiltrate pro secucas cannot be excluded from having a possible causal or contributory role in the patient¿s serious adverse events.Without hospital records, a discharge summary, treatment records or a manufacturer evaluation of the suspect product, this clinical investigation cannot disassociate the multifiltrate pro secucas from the serious adverse events.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: a blood contaminated multifiltrate bloodline was returned to the manufacturer for evaluation.The multifiltrate bloodline was without the ¿blister packaging¿ [sic].As such, the batch number could not be determined.A visual inspection of the sample was performed.The sample was inspected for component defects, assembly failure, and conformity with the product specifications.The sample was then subjected to a leakage test and exposed to air and liquid pressure to further test for assembly failure and leakage.Upon completion of the examination, no component defects, assembly failure, or air/liquid leakages were observed.The sample was found to be conforming with product specifications.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.The production department has been informed about this issue, and product surveillance will continue to monitor complaints of this type for adverse trends.

Event Description

It was reported that a patient with acute kidney injury (aki) on continuous renal replacement therapy (crrt) experienced a cardiopulmonary arrest following the discontinuation of treatment.The complaint documentation revealed the patient was hospitalized for the surgical removal of an aortic stent due to an ia endoleak (blood leakage at anastomosis site).Following the procedure, the patient required mechanical ventilation due to hemodynamic instability, in addition to septic shock, pneumopathy (lung infection), and aki.The patient was admitted to the intensive care unit (icu) and a temporary hemodialysis (hd) catheter (not a fresenius product) was placed for the purposes of crrt therapy.On (b)(6) 2023, at approximately 8:00 am (local time) the patient¿s crrt treatment was completed (without reported issue), and the patient¿s extracorporeal blood was reinfused.Following reinfusion, the patient became agitated, and it was discovered air (embolism) had entered the patient¿s body (at least 10 ml after aspiration) via the inlet line.Shortly after termination the patient became hypotensive (value not provided), bradycardic (heart rate = 40 bpm), lost consciousness, and subsequently experienced a cardiopulmonary arrest.Cardiopulmonary resuscitative (cpr) measures were implemented and after approximately 10 minutes the patient regained ¿circulatory activity¿ (specifics not provided).The patient was transferred to a hyperbaric chamber following the serious adverse events, and the patient¿s temporary hd catheter was removed and replaced with an internal jugular catheter (not a fresenius product) for further rrt.The patient¿s current disposition is unknown.

• 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: 17012921
• MDR Text Key: 316043033
• Report Number: 0001225714-2023-00036
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 36-8116-0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male