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

Catalog Number 107493

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 09/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, the patient experienced an increased calcium level.It was reported the treatment was performed for six days using regional citrate for anticoagulation and calcium was used via an external infusion pump.Crrt was discontinued due to another indication; however, the external calcium infusion was not stopped by the operator at the same time as crrt was stopped.The patient¿s ionized calcium reportedly increased, and an unreported medical intervention was required to treat the hypercalcemic condition.It was reported the event was resolved in 24-48 hours.No clinical symptoms were reported.No additional information is available.

Manufacturer Narrative

H10: the device was not returned for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Based on available information, there was no evidence that a malfunction of the prismaflex caused the reported event.The reported event was caused by a user error as the external calcium infusion pump was not stopped when stopping the continuous renal replacement therapy.Regional citrate anticoagulation is not approved as anticoagulant method when using the prismaflex control unit with software 7.Xx and the control unit is therefore not designed to generate a notification to stop the calcium infusion when an external pumping device is used for calcium infusion.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction: removal of information in section f related to importer - the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9357102
• MDR Text Key: 185194778
• Report Number: 9616026-2019-00059
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019,12/18/2020

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: 107493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2019
• Distributor Facility Aware Date: 10/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/21/2019
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 12/17/2019; 12/17/2020
• Supplement Dates FDA Received: 12/19/2019; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CALCIUM; EXTERNAL INFUSION PUMP; REGIONAL CITRATE
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR