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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 Problem 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 pump constantly displayed the close door message.It was also reported there was no patient injury.
 
Manufacturer Narrative
(b)(4).Baxter received and evaluated the device.The device was found out of specification in relation to the constant close door messages which were experienced during evaluation by observing a door not fully latch alarm when loading a set and closing the door.Further evaluation found the door able to latch close with a loaded iv set, however, force required to secure door is above expected levels.This was caused by failed door hooks and latch pins.The door hooks and latch pins were replaced.
 
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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 quality mgr
711 park ave.
medina, NY 14103
8003563454
MDR Report Key4489747
MDR Text Key5495853
Report Number1314492-2015-01683
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 Health Professional
Reporter Occupation Biomedical Engineer
Remedial Action Repair
Type of Report Initial
Report Date 01/12/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2015
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? Yes
Date Returned to Manufacturer01/19/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2011
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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