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 Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

While attempting to disconnect the access line to begin reinfusion during continuous veno-venous hemodialysis (cvvhd) treatment, it was reported that the end of the access line looked ¿mangled¿.Upon further inspection, the end of the access line appeared to have snapped and lodged in the access lumen of the vascath.The medical staff attempted to dislodge the end of the line from the vascath, but they were unsuccessful.They were unable to wash back the filter or use the vascath.The staff was informed that the patient may need another unit of blood (one already running) and would need a replacement vascath inserted.The reported event resulted in approximately 200 ml (or less) of blood loss.The complaint sample was not available to be returned for evaluation.Multiple attempts have been made to obtain additional information, and thus far no further details have been provided.

Manufacturer Narrative

Plant investigation: the actual complaint sample was not returned for physical evaluation.Retained samples were evaluated instead.The retained samples were inspected visually and checked for component defects, assembly failure, and conformity with product specifications.No failures were detected on the retained samples.The samples were found to be conforming with the product¿s technical drawings.The described situation is adequately addressed in the instructions for use (ifu) and/or on the label.A production records review was performed on the reported lot.All batch production record controls were found to be conforming.No non-conformities were observed during the manufacturing process.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint was not confirmed.

Event Description

While attempting to disconnect the access line to begin reinfusion during continuous veno-venous hemodialysis (cvvhd) treatment, it was reported that the end of the access line looked ¿mangled¿.Upon further inspection, the end of the access line appeared to have snapped and lodged in the access lumen of the vascath.The medical staff attempted to dislodge the end of the line from the vascath, but they were unsuccessful.They were unable to wash back the filter or use the vascath.The staff was informed that the patient may need another unit of blood (one already running) and would need a replacement vascath inserted.The reported event resulted in approximately 200 ml (or less) of blood loss.The complaint sample was not available to be returned for evaluation.Multiple attempts have been made to obtain additional information, and thus far no further details have been 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: 18909085
• MDR Text Key: 337761197
• Report Number: 0001225714-2024-00027
• 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,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 36-8116-0
• Device Lot Number: D9UK223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/18/2024
• 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