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

Model Number PRISMAFLEX HF20

Device Problem Output Problem (3005)

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

Event Date 09/19/2021

Event Type  malfunction  

Event Description

Prismaflex hf-20 filter blood primed for crrt.Approximately 30 minutes following initiation, effluent in bag was blood tinged.Nephrology & picu team paged, all to bedside to monitor.Patient cell count sent to lab stat: resulted in rbc <2000.Circuit taken down.The patient was put onto a new crrt circuit at 1056, and brand-new filter used.Team noticed pink tinged effluent in bag and pod around 1115, for a second time.Crrt dialysis drew a cell count and sent it to lab stat.No blood leak alarm on crrt pump.Lab resulted rbc <2000.Crrt stopped, and nephrology & picu team paged back to bedside.Patient taken off crrt at 1226.The filters with this lot number have been pulled from service, and the prismaflex machine placed out of service.The concern with blood in the effluent line means there is a break in the filter, and the filter is compromised, allowing dialysate to get to the patient's blood freely.The patient's electrolytes and blood cultures were sent, and patient was on prophylactic antibiotics.The patient¿s labs were within this specific patient¿s norm, and the patient is currently not showing any signs of an infection.

Event Description

Prismaflex hf-20 filter blood primed for crrt.Approximately 30 minutes following initiation, effluent in bag was blood tinged.Nephrology & picu team paged, all to bedside to monitor.Patient cell count sent to lab stat: resulted in rbc <2000.Circuit taken down.The patient was put onto a new crrt circuit at 1056, and brand-new filter used.Team noticed pink tinged effluent in bag and pod around 1115, for a second time.Crrt dialysis drew a cell count and sent it to lab stat.No blood leak alarm on crrt pump.Lab resulted rbc <2000.Crrt stopped, and nephrology & picu team paged back to bedside.Patient taken off crrt at 1226.The filters with this lot number have been pulled from service, and the prismaflex machine placed out of service.The concern with blood in the effluent line means there is a break in the filter, and the filter is compromised, allowing dialysate to get to the patient's blood freely.The patient's electrolytes and blood cultures were sent, and patient was on prophylactic antibiotics.The patient¿s labs were within this specific patient¿s norm, and the patient is currently not showing any signs of an infection.

• Brand Name: PRISMAFLEX HF20
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE; one baxter parkway; deerfield IL 60015
• MDR Report Key: 13577434
• MDR Text Key: 285941263
• Report Number: 13577434
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRISMAFLEX HF20
• Device Lot Number: FILTER FOR HF20 WAS 21A1203Z
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 120 DA
• Patient Sex: Male