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

Catalog Number 955792

Device Problem Protective Measures Problem (3015)

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

Event Type  malfunction  

Manufacturer Narrative

The occurrence date was reported to be between (b)(6) and (b)(6) 2021.Should additional relevant information become available, a supplemental report will be submitted.

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

H10: the log file analysis was performed.Based on the data of the log files, no anticoagulation therapy was delivered along the whole treatment.The causes for sessions interruption were mainly warning filter clotted, caution: tmp excessive or warning: filter pressure extremely positive; the common scenario behind all these causes is a filter progressive clogging due to association of no anticoagulation, replacement fluid delivered 100% post filter and quite high patient fluid removal rates (about 200 ml/h); the limited volume and the very small membrane total surface of hf20 requires a particular surveillance of the treatment.The causes for the repeated filter clotting and excessive pressure drop across the filter, and for excessive tmp pressure were mainly associated with the treatment setting.Based on the investigation objective elements, there wasn¿t any evidence that malfunction of prismaflex pa32971 caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• 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 - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12908797
• MDR Text Key: 283606859
• Report Number: 9616026-2021-00071
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414126766
• UDI-Public: (01)07332414126766(21)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131516
• 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
• Report Date: 02/14/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX HF20 SET
• Patient Outcome(s): Required Intervention
• Patient Weight: 19 KG