• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

NOVAMED (ANTALYA) MULTIFILTRATEPRO SECUCAS CI-CA HD; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 36-8116-0
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/27/2023
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 white stripes in return tubing in the ci-ca cvvhd kit used in combination with ci-ca dialysate plus during the patient¿s continuous venovenous hemodialysis (cvvhd) treatment.The patient had high fibrinogen.The patient was disconnected from tubing and the treatment was restarted with new tubing and ci-ca dialysate.The patient¿s blood which resulted in approximately 200 ml of blood loss.The sample was reported to not be available for evaluation.Additional information requested but has not been obtained.
 
Event Description
Additional information received confirmed that the multifiltrate pro machine was used during treatment.The treatment was completed on the same machine, however a different kit and type of dialysate (without phosphate instead of phosphate-containing dialysate) was used.
 
Manufacturer Narrative
Investigation: the sample was not returned.Batch production record controls resulted with conformity.Nonconformity was not observed during manufacturing process.Complaint history review confirmed there was no other complaint reported for the batch.The reported event is adequately addressed in the instructions for use and/or the label.There is no indication that the reported failure relates to falsification.The retained samples evaluation confirmed there was no failure detected.According to the results of the production group investigation, no change was observed to the production or manufacturing processes.The complaint was admitted and associated to supplied material due to possible inadequate product design.
 
Event Description
Additional information received confirmed that the multifiltrate pro machine was used during treatment.The treatment was completed on the same machine, however a different kit and type of dialysate (without phosphate instead of phosphate-containing dialysate) was used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18493968
MDR Text Key332767741
Report Number0001225714-2024-00001
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
EUA200149
Number of Events Reported1
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 01/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number36-8116-0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 12/21/2023
Initial Date FDA Received01/11/2024
Supplement Dates Manufacturer Received01/15/2024
01/05/2024
Supplement Dates FDA Received01/15/2024
01/16/2024
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 Number1
Treatment
MULTIFILTRATE PRO MACHINE.; MULTIFILTRATE PRO MACHINE.
-
-