MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107640

Device Problem Fluid/Blood Leak (1250)

Patient Problems Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number: (b)(6).Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization (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 Description

It was reported that an internal blood leak was observed on two (2) units of a prismaflex st150 set during patient use.When treatment was started, the tests were ok and the patient was connected, however, later they observed that the blood was ending up in the effluent bag.A flow alarm and air alarm were triggered.The patient was disconnected and blood was not returned.A re-test of another kit on another machine was performed and again, blood was observed in the effluent at the patient's connection.The patient was disconnected without blood return.The patient experienced a progressive decrease in their hemoglobin level and a 3-4 hour delay in treatment.The customer could not provide the clinical symptoms as the patient was ¿resuscitating¿.No additional information is available.

Manufacturer Narrative

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.

Manufacturer Narrative

H10: the actual device was not received; however, two companion samples were received for evaluation.A visual inspection and simulated test were performed and the reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX ST150
• Type of Device: 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 ; 2242702068
• MDR Report Key: 12894761
• MDR Text Key: 281420148
• Report Number: 8010182-2021-00366
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107640
• Device Lot Number: 21G0205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: No
• 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: PRISMA/BAXTER BRAND MACHINE.
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female