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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 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.
 
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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 22643
SW 22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9667762
MDR Text Key177676882
Report Number9616026-2020-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072093
Number of Events Reported1
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 Received02/04/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number107493
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/04/2020
Distributor Facility Aware Date01/06/2020
Event Location Hospital
Date Report to Manufacturer02/04/2020
Date Manufacturer Received03/11/2020
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
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