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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF1400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107142
Device Problem Disconnection (1171)
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
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
The customer reported this event to the fda through medwatch 5096970. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NamePRISMAFLEX HF1400
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
7, av lionel terray, b.p. 126
meyzieu cedex rhone 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10693092
MDR Text Key211757376
Report Number8010182-2020-00213
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K042938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/15/2020,11/25/2020
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 Number107142
Device Lot Number20F0305
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 Received11/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/16/2020 Patient Sequence Number: 1
Treatment
PRISMAFLEX CONTROL UNIT; PRISMAFLO BLOOD WARMER
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