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

Catalog Number 955052

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Shock (2072); Blood Loss (2597)

Event Date 05/22/2019

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a use error occurred while a patient was being treated with continuous renal replacement therapy (crrt) using a prismaflex control unit and a prismaflex set in addition with an ecmo machine piggybacked onto the prismaflex extracorporeal circuit.The event occurred in the intensive care unit where the patient was being treated for an unrelated critical illness.The use error was further described as the operator, when prompted by the prismaflex to replace the dialysate bag, erroneously pushed the wrong button to stop treatment and then unloaded the set whilst the patient was still connected; all applicable warning/safety messages were overridden by the operator.As a result, the patient¿s blood was drained into the fluid bags and the patient went into shock and the bags were quickly clamped.Resuscitation measures which included blood transfusion, was successful and crrt was restarted.At the time of this report the patient's condition was reported as still critically ill.No additional information is available.

Manufacturer Narrative

A service history review was conducted and there were no deviations found related to this reported condition.A device history review revealed no issues that could have caused or contributed to the reported issue.The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided photos confirmed when the prismaflex machine asked to replace the dialysate bag, the operator erroneously pushed the button to stop treatment and then unloaded the set while the patient was connected, ignoring and overriding all applicable warning/safety messages.The cause of the reported issue was due to use error.The operator's manual gives instruction and warns that the prismaflex control unit is operated by appropriately trained and qualified staff.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 - LUND MONITORS; lund skane lan
• MDR Report Key: 8707905
• MDR Text Key: 148299583
• Report Number: 9616026-2019-00036
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955052
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/05/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECMO MACHINE; ECMO MACHINE
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR