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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 115269
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 02/25/2019
Event Type  Injury  
Manufacturer Narrative
(b)(6). 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, crrt, using a prismaflex control unit and a prismaflex filter set experienced blood loss and hypotension. A communication error, code 7 alarm, was reportedly generated causing the prismaflex to enter a patient safe state and resulting in the termination of treatment. Manual blood return was attempted, but the operator accidentally connected the saline bag to the return line and an unspecified volume of blood was entering the saline bag instead of being returned to the patient. The patient reportedly became severely hypotensive, but no information was provided related to medical intervention provided. The patient outcome was not reported. No additional information is available.
 
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Brand NamePRISMAFLEX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - LUND MONITORS
lund skane lan
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 Key8444873
MDR Text Key139593539
Report Number9616026-2019-00013
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
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 03/22/2019,04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number115269
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/22/2019
Distributor Facility Aware Date02/26/2019
Event Location Hospital
Date Report to Manufacturer03/22/2019
Date Manufacturer Received04/19/2019
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: 03/22/2019 Patient Sequence Number: 1
Treatment
PRISMAFLEX SET
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