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

Catalog Number	955792
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• 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 - 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
• Report Number: 9616026-2021-00071
• Device Sequence Number: 4963042
• Product Code: KDI
• UDI-Device Identifier: 07332414126766
• UDI-Public: (01)07332414126766(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 955792
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAFLEX HF20 SET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 19 KG