MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF20; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 109841

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

It was reported that during continuous renal replacement therapy on a pediatric patient using a prismaflex control unit and four (4) units of a prismaflex hf20, self-test failure (4, pressure pod/sensor issue) alarms were generated and at least one of the treatment was ended without the extracorporeal blood being returned to the patient.A blood transfusion was performed on the patient.No additional information is available.No additional information is available.

Manufacturer Narrative

Date of event: the occurrence date was reported to be between (b)(6) 2021.Prismaflex hf20 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to provide continuous renal replacement therapy (crrt) to treat low weight (8 kg to 20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the coronavirus disease 2019 (covid-19) pandemic.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; however, pictures were presented for inspection.The visual inspection of the provided photos did not identifying any specific defect on the impacted set.Therefore, it is undetermined if a product defect caused or contributed to the reported alarm generated by the control unit.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX HF20
• 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: 12908796
• MDR Text Key: 281514536
• Report Number: 8010182-2021-00367
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414089443
• UDI-Public: (01)07332414089443(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 109841
• Device Lot Number: 21A1203Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• 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: PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Required Intervention