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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 Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
It was reported that a spectrum pump constantly displayed door not fully latched message.Any patient involvement, injury or medical intervention is unk.
 
Manufacturer Narrative
(b)(4).Baxter received and evaluated the device.The device was found out of specification in relation to door not fully latched messages which were reproduced during evaluation and is what the reported "door open alarm" most likely referring to.The door latches close, but with excessive force being required to close door.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 Key4696431
MDR Text Key19613816
Report Number1314492-2015-00979
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 12/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2015
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 Manufacturer01/05/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2013
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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