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

Catalog Number 113082

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient being treated with continuous renal replacement therapy (crrt) involving a prismaflex control unit became hypotensive during therapy.The ultrafiltration rate was set at 70 ml/h.The reporter stated that for an hour, there were ¿numerous¿ flow rate alarms with the blood pumps stopped, and the patient was hypotensive.Upon review, it was noticed that the patient experienced an excessive fluid removal of 359 ml/h instead of 70 ml/h.Unspecified "pressors" was administered, the hemodynamic instability was resolved, and the pressors were successfully titrated down.The patient successfully completed treatment and required no additional medical intervention.No additional information is available.

Manufacturer Narrative

The device was not received for evaluation.The event history log review showed that the gain/loss limit was set to the default 400ml for the treatment.The gain/loss limit was never reached for the treatment.The gain/loss limit is a prescribed value which is to be set according to the prescribing clinicians evaluation of the patient's tolerance for an eventual fluid deviation.The alarms were triggered several times and each time they were confirmed without the operator taking the necessary action to correct the cause of the alarm.This is therefore a use error.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: 7545677
• MDR Text Key: 109310820
• Report Number: 9616026-2018-00008
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K110823
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 113082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX ST150 SET; PRISMAFLEX ST150 SET
• Patient Outcome(s): Other