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

Catalog Number 113082

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that calcium anticoagulant was over infused during continuous renal replacement therapy (crrt) while using a prismaflex machine.At an unknown time during treatment, it was identified that the provided calcium concentration did not correspond to the calcium concentration set as default in the control unit.The reporter stated that the prismaflex machine was found to be incorrectly configured by the operator with the wrong calcium solution.The operator is prompted by the screen on the prismaflex control unit to assess the default flow rates and syringe settings, to make any changes desired for the current treatment and to confirm all values shown on the ¿enter anticoagulation settings¿ screen prior to starting the treatment.It was not reported why the operator failed to observe the prompts on the on the prismaflex screen.The machine was reconfigured to calcium solution as per local prescription.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation; therefore, a device evaluation could not be performed.However, based on the information provided by the customer the likely cause of the reported event was determined to be an incorrect calcium configuration followed by a use error of not observing the incorrect configuration prior to initiating therapy.The anticoagulation solutions settings in the prismaflex control unit were most likely not configured by the authorized technician according to the anticoagulation solutions used in the clinic.Per the operator¿s manual, ¿for the "citrate - calcium" methods, service and custom configurations are also required.Through the service mode, an authorized service technician can configure the citrate and/or calcium solution parameters to be used during treatment, according to the facility's demands.Contact the local representative for additional information.Through the custom mode, the operator selects which citrate or calcium solution(s) to use for the treatment.¿ during the setup procedure the operator chooses the prescribed settings desired for the current treatment.The operator is then asked to confirm all values in the ¿review prescription¿ screen prior to starting the treatment.Treatment was initiated although the prismaflex settings did not match the prescribed settings with respect to the used calcium solutions concentration.There is no data to reasonably suggest that the prismaflex control unit malfunctioned in the reported event.The anticoagulation solutions in the prismaflex control unit was reported to have been corrected to match the anticoagulation solutions used by the clinic.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device evaluation could not be performed.However, based on the information provided by the customer the likely cause of the reported event was determined to be an incorrect calcium configuration followed by a use error of not observing the incorrect configuration prior to initiating therapy.The anticoagulation solutions settings in the prismaflex control unit were most likely not configured by the authorized technician according to the anticoagulation solutions used in the clinic.Per the operator¿s manual, ¿for the "citrate - calcium" methods, service and custom configurations are also required.Through the service mode, an authorized service technician can configure the citrate and/or calcium solution parameters to be used during treatment, according to the facility's demands.Contact the local representative for additional information.Through the custom mode, the operator selects which citrate or calcium solution(s) to use for the treatment.¿ during the setup procedure the operator chooses the prescribed settings desired for the current treatment.The operator is then asked to confirm all values in the ¿review prescription¿ screen prior to starting the treatment.Treatment was initiated although the prismaflex settings did not match the prescribed settings with respect to the used calcium solutions concentration.There is no data to reasonably suggest that the prismaflex control unit malfunctioned in the reported event.The anticoagulation solutions in the prismaflex control unit was reported to have been corrected to match the anticoagulation solutions used by the clinic.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: 7875005
• MDR Text Key: 120259000
• Report Number: 9616026-2018-00016
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 113082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON-BAXTER CALCIUM ANTICOAGULANT.