MAUDE Adverse Event Report: BAXTER HEALTHCARE PRISMAFLEX SETS (M ); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109990

Device Problems Obstruction of Flow (2423); Filtration Problem (2941)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) with a prismaflex m150 set three events of clotting were observed.The first clot was observed in the aerator chamber, specified as ¿stuck in tubing above aerator chamber towards the tmp¿.The patient's lines were reversed, the blood pump increased and decreased to try and resolve.It was reported the ¿filter clotted at this time¿.Therapy was ¿paused for remainder of night¿.According to the reporter after therapy was resumed, they were unable ¿to return blood at this time due to filter clotting¿.After disconnecting the return line the clot was observed in the luer lock.The access port was flushed; however, the blood return was not noted.The port was flushed a second time and blood return was noted.It was further reported the extracorporeal (ec) blood was not returned 2 times.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, three companion samples were received for evaluation.Visual inspection of the companion samples did not identify any abnormalities that could have contributed to the reported condition.A short simulated therapy was successfully performed.No leaks or cracks were identified.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS (M )
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15240351
• MDR Text Key: 304789334
• Report Number: 8010182-2022-00235
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 109990
• Device Lot Number: 21L0010CE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2022
• 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: HEPARIN; TRISODIUM CITRATE