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.

• 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
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan 22643 ; SW 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• 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
• Reporter Country Code: SF
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 955052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 06/18/2019 Patient Sequence Number: 1

Treatment

ECMO MACHINE