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

Catalog Number 955542

Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2019

Event Type  malfunction  

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 using a prismaflex control unit and an unspecified type of prismaflex set, a non baxter product (tego connector) was used (contrary to the warning in the prismaflex operator¿s manual) between the catheter and access and return blood lines.The tego connector became disconnected from the return part of the unspecified type of catheter and no alarm was reportedly generated.The tego connector remained connected to the return line.The patient lost approximately two liters of blood by the time the disconnection was discovered.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h6 and h10.H10: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, the clinical practice described in the reported condition of connection of the patient return line to the catheter using tegos cap is not allowed as per prismaflex operator¿s manual.The user is asked to connect the return line directly to the blood access device, avoiding additional devices between the return line and the blood access device.The use of additional devices (like tegos caps) may compromise the return pressure monitoring, impeding the detection of return disconnections with potential blood loss.The cause of the reported event is 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: 8680057
• MDR Text Key: 147646528
• Report Number: 9616026-2019-00034
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/07/2019,07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955542
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/07/2019
• Distributor Facility Aware Date: 05/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2019
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TEGO CONNECTORS.
• Patient Outcome(s): Other