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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
Model Number N/A
Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/03/2017
Event Type  malfunction  
Manufacturer Narrative
The issue occurred approximately half an hour after the start of therapy. The patient was continuously monitored by a staff member. The reporter stated that the patient did not physically pull the line. The disconnection issue was noted when another staff member approached the other side of the bed and noticed blood on the patient. The device was evaluated on-site by a technician. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Testing and troubleshooting were performed with no issues noted. Functional testing was performed by dropping the return pressure to zero multiple times. The machine correctly returned a return disconnection alarm after 15 seconds each time. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. The reported condition was not verified. The device was found to operate per specification. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
The reporter stated that the customer called the helpline as the prismaflex machine did not alarm when the return line became disconnected from the catheter. There was some blood loss into the bed which was estimated at approximately 200ml. The customer reconnected the return line to the catheter and the machine gave the 'return disconnection alarm'. The machine then presented a 'system failure' alarm. There was no patient injury or 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 Key7143248
MDR Text Key261993749
Report Number9616026-2017-00067
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number113874
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2018
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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