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

Catalog Number 107493

Device Problems No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 01/06/2020

Event Type  Death  

Manufacturer Narrative

This is related to mfr report# 8010182-2020-00008. Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient was being treated with continuous renal replacement therapy using a prismaflex control unit, a prismaflex hf1400 filter set and a tego connector (non-baxter product). The tego connector was being used in accordance to hospital practice and was attached to the patient's angiodynamics vas-cath which was positioned in the left internal jugular and the vas-cath was reportedly covered by a blanket. Treatment had been running for more than nineteen (19) hours when the prismaflex hf 1400 set (return blood line) became disconnected from the tego connector resulting in blood loss and the patient subsequently passed away. The prismaflex operator¿s manual warns that the use of additional devices between the return line and the blood access device can impair return pressure monitoring and the detection of return disconnections, potentially resulting in severe blood loss. No alarm was generated by the prismaflex control unit because of the disconnection. The operator was alerted by a cardiac monitor as the patient presented with bradycardia. The nurse responded to the alarm and assessed airway. The red and blue lines of the set were clamped, and the machine was stopped. It was reported that an autopsy will be performed. No additional information is available. This event is the same event as the one reported through medwatch # 8010182-2020-00008 for the prismaflex hf1400 set.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan 22643 ; SW 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9667762
• MDR Text Key: 177676882
• Report Number: 9616026-2020-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020,04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Distributor Facility Aware Date: 01/06/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/04/2020 Patient Sequence Number: 1

Treatment

CARDIAC MONITOR; CATHETER; ICU MEDICAL TEGO CONNECTOR; PRISMAFLEX SET- PRODUCT CODE 107142