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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, 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 Key10693085
MDR Text Key211757884
Report Number9616026-2020-00031
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K131516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955792
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/15/2020
Distributor Facility Aware Date09/22/2020
Event Location Hospital
Date Report to Manufacturer10/15/2020
Date Manufacturer Received11/12/2020
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 Treatment Data
Date Received: 10/16/2020 Patient Sequence Number: 1
Treatment
PRISMAFLEX HF1400; PRISMAFLO BLOOD WARMER
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