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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - BROOKLYN PARK THERMAX BLOOD WARMER DISPOSABLE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE - BROOKLYN PARK THERMAX BLOOD WARMER DISPOSABLE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955516
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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. The rupture of the blood warmer bag was associated with a use error when performing the manual blood restitution to the patient. The manual clamp on the return line was not released by the operator before using the crank. Manual blood return instructions are provided in the prismax operator's manual which is provided with every prismax monitor. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported during continuous renal replacement therapy (crrt), using a thermax blood warmer bag, a use error occurred which led to an external blood leak. It was further specified that the event occurred due to an incorrect manual blood restitution procedure. It was reported the healthcare professional did not release the clamp on the return line before using the crank. The amount of external blood loss was estimated to be 50 ml. It was reported the blood was not returned to the patient. It was reported the patient ¿remained stable¿. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameTHERMAX BLOOD WARMER DISPOSABLE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - BROOKLYN PARK
minneapolis MN
Manufacturer (Section G)
BAXTER HEALTHCARE - BROOKLYN PARK
7601 northland drive
n suite 170
minneapolis MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9049147
MDR Text Key216645455
Report Number3003504604-2019-00007
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955516
Device Lot Number18K01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2019
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

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