MAUDE Adverse Event Report: GAMBRO LUNDIA AB PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PRISMAFLEX

Device Problems Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Overdose (1988)

Event Date 07/25/2015

Event Type  malfunction  

Manufacturer Narrative

Analysis of the treatment history data downloaded from the used prismaflex control unit has been performed.The analysis shows the alarm "malfunction code : syringe pump(5)" was triggered twice during the treatment.The alarm was triggered in connection with a new syringe installed in its holder.This type of alarm will force the control unit into a patient safe state mode; this prevents the treatment from continuing until the operator clears the alarm.The analysis of the data shows that the alarm was cleared both times it was issued.Prior to the second event, the ¿anticoag continuous rate¿ was set by the operator to zero; thereafter, the treatment continued until the operator chose to end the treatment approximately 24 hours later.A technical investigation on the prismaflex® control unit was performed by a hospital technician and he replaced the syringe pump, however it is not stated if the technician could reproduce the reported problem.The defective syringe pump has been requested and will be analyzed by the manufacturer when it has arrived.

Event Description

A septic patient with acute kidney injury who was undergoing crrt on a prismaflex control unit unintentionally received a 2500 iu heparin bolus when the syringe pump failed to stop at the plunger of the syringe.The nurse stopped the syringe manually.No medical intervention was reported and the treatment continued.The patient's aptt was reported to be low therefore, the patient's coagulation levels were monitored until they returned to normal.The patient did not require medical intervention as a result of the heparin bolus.It was reported the patient expired the following day as a result of his underlying medical condition.No autopsy was performed.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO LUNDIA AB; box 10101; lund SE-22 010; SW SE-22010
• Manufacturer Contact: magnus persson ; box 10101; lund ; SW ; 46169000
• MDR Report Key: 5036940
• MDR Text Key: 25296050
• Report Number: 9616026-2015-00021
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: PRISMAFLEX
• Device Catalogue Number: 113874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2014
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 60