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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 107493
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The device was evaluated on site. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Functional testing was performed which included air bubble testing, prime and simulated run. Air bubble testing passed with no issues found. Prime and simulated run verified the air bubble function with no issues found and no repairs needed. The reported condition was not verified. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The cause of the condition could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, the machine triggered an air in blood alarm. The alarm occurred at an unspecified time during treatment. The cause of the alarm was unknown. It was reported there was no visible air detected and troubleshooting was unsuccessful. Treatment was discontinued. The extracorporeal blood in the circuit was not returned to the patient. There was no report of medical intervention associated with this event. 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 SE-22 643
SW SE-22643
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8370220
MDR Text Key139585588
Report Number9616026-2019-00007
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,consum
Reporter Occupation
Type of Report Initial
Report Date 02/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number107493
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/26/2019
Distributor Facility Aware Date02/02/2019
Event Location Hospital
Date Report to Manufacturer02/26/2019
Date Manufacturer Received02/02/2019
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

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