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

Catalog Number 955792

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Exsanguination (1841)

Event Date 09/22/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the return line of a prismaflex hf1400 set became disconnected (either partially or completely) from the patient's tunnelled dialysis catheter which caused the patient to exsanguinate and subsequently pass away.Reportedly, the prismaflex control unit did not issue an alarm.It was reported that the nurse found the patient in agonal breathing and checked the patient's catheter insertion site but not the actual return line connection point to the catheter.It was also reported that the patient had several blankets and a warming blanket placed over the torso which blocked the visual inspection of the connection points.Resuscitation with fluid and medications was unsuccessful and the patient subsequently passed away.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

The customer reported this event to the fda through medwatch 5096970.The device was not received for evaluation however, one day after the event, the device was inspected by a local service engineer and no technical defects or abnormalities that could have contributed to the reported condition were identified.The device passed all tests and a simulated treatment was run for 30 minutes without any technical issues.The event history log was reviewed, and no machine failure was identified in the analysis.It was noted that the alarms generated by the machine were cleared by the operator six seconds after issuance, indicating that no troubleshooting was performed in relation to the alarms.Treatment was continued without ensuring that the catheter and return line where connected, allowing for further blood loss.The alarm screen for return pressure dropping alarm clearly instructs the operator to ¿make sure return catheter is securely connected to both the return line and the patient¿.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.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 CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10693085
• MDR Text Key: 211757884
• Report Number: 9616026-2020-00031
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/15/2020,12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955792
• 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: 10/15/2020
• Distributor Facility Aware Date: 09/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX HF1400; PRISMAFLO BLOOD WARMER
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 109