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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP SPECTRUM INFUSION PUMP
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BAXTER HEALTHCARE CORP SPECTRUM INFUSION PUMP Back to Search Results
Model Number 35700
Device Problems Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2015
Event Type  malfunction  
Event Description
It was reported that a spectrum infusion pump's door would not latch close.It was also reported that there was no patient injury.
 
Manufacturer Narrative
(b)(4).The device was returned to baxter and an evaluation was performed.The evaluation confirmed (through the history log as door jammed alarms) but did not reproduce the reported "door will not latch close." the force required to the secure door was above expected levels corresponding with reported symptom.The device was calibrated to correct this condition.
 
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Brand Name
SPECTRUM INFUSION PUMP
Type of Device
INFUSION PUMP
Manufacturer (Section D)
BAXTER HEALTHCARE CORP
medina NY
Manufacturer Contact
kelly morse,sr.mgr, quality
711 park ave.
medina, NY 14103
8003563454
MDR Report Key4539198
MDR Text Key5353036
Report Number1314492-2015-02562
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042121
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Remedial Action Repair
Type of Report Initial
Report Date 01/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number35700
Device Catalogue Number35700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received01/28/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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