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

Catalog Number	107636US
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Prismaflex st100 set has been temporarily approved for use in the us under emergency use authorization eua (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a foreign material clogged the filter and a "rubber like thread" was observed in the return line of a prismaflex st100set during continuous renal replacement therapy.The set was replaced to continue treatment.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Correction made to d1: brand name: prismaflex sets (st) (previously submitted as prismaflex sets) correction made to h5: label for single use? yes (previously submitted as no) additional information was added to h6 and h11: h11: the device malfunction, this is a report of a patient of unknown age and gender, who was treated with continuous renal replacement therapy, crrt, using a prismaflex st100 set when"rubber like thread" was observed and there was ¿foreign bits/ strange fluid¿ in the return line.In addition the previous filter clogged.No further clarification was reported and the sample was not saved.No microscopic or biochemical analyses of the white deposits was reported but the particles may have been white thrombus formation formed by an aggregation of platelets and fibrin.This is likely associated with patient specific as well as device specific factors.No serious adverse events such as pulmonary embolism, myocardial infarction, cerebrovascular accident, or other thromboembolic events were noted in connection with the formation of white thrombus and investigations showed that the white thrombus formation was independent of dialyzer membrane chemistry or manufacturer.Based on the degree of clotting in the extracorporeal (ec) circuit it may, or may not, be possible to return the entire ec blood volume to the patient.No, patient symptom or medical intervention was reported and the event is classified as no serious injury.If the ec blood is not returned, the blood loss will be limited to the ec circuit, which accounts for 5-10 % of the patient¿s blood volume.Losing this volume of blood is not expected to result in any significant patient harm in a vast number of patients.This does not have the likelihood to cause or contribute to death or serious injury.The coagulation cascade is activated when blood meets the blood lines and the filter/dialyzer and potential causes of clotting include: presence of air in the extracorporeal circuit (inadequate priming or air entry), low blood flow rate, frequent alarm conditions causing blood pump stops, incorrect or inadequate delivery/prescription of anticoagulant as well as underlying medical condition of the patient.In conclusion, it is undetermined if the prismaflex st100 set, however in combination with underlying medical condition and applied treatment parameters, caused or contributed to the non-serious event of clotting associated with possible blood loss.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS (ST)
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 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 60073 ; 2242702068
• MDR Report Key: 19749895
• Report Number: 8010182-2024-00315
• Device Sequence Number: 15704473
• Product Code: KDI
• UDI-Device Identifier: 00085412954073
• UDI-Public: (01)00085412954073(10)23F0089CC(17)250531
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 107636US
• Device Lot Number: 23F0089CC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown