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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 Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017)
Patient Problem Death (1802)
Event Date 01/06/2020
Event Type  Death  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a patient who was being treated with continuous renal replacement therapy using a prismaflex control unit, a prismaflex hf1400 filter set and a tego connector (non baxter device) "bleed out" and subsequently passed away. It was reported that in accordance with the facility clinical practice, the tego connector (non baxter device) was connected between the patient catheter (non baxter device) and the return blood lines. Treatment had been running for more than nineteen (19) hours when the return blood line became disconnected from the tego connector. No alarm was generated by the prismaflex control unit as a result of the disconnection. The operator was alerted by a cardiac monitor as the patient presented with bradycardia and the patient had ¿bleed out¿. The nurse responded to the alarm and assessed airway. The red and blue lines of the set were clamped and the machine was stopped. The estimated blood loss was reported as approximately 150-200ml. The patient subsequently passed away. It was reported that an autopsy will be performed. No additional information is available.
 
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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 Key9662285
MDR Text Key177531322
Report Number8010182-2020-00008
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 02/03/2020,03/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date07/01/2021
Device Catalogue Number107142
Device Lot Number19G1003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2020
Event Location Hospital
Date Report to Manufacturer02/03/2020
Date Manufacturer Received03/05/2020
Was Device Evaluated by Manufacturer? Yes
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: 02/03/2020 Patient Sequence Number: 1
Treatment
CARDIAC MONITOR; CATHETER; PRISMAFLEX MACHINE PRODUCT CODE: 106913; TEGO CONNECTOR
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