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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 Break (1069); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2015
Event Type  malfunction  
Event Description
It was reported that a spectrum pump door will not completely shut due to a broken door switch.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 with respect to the door that would not completely shut due to a broken door switch.During evaluation, a door not fully latched alarm was observed after loading a set which occurs when the pump does not recognize a closed door.This is most likely what the customer was referring to.The messages were found to be caused by a failed upper link switch on the upper auxiliary assembly.The failed upper auxiliary assembly was 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, mgr
711 park ave.
medina, NY 14103
8003563454
MDR Report Key4710588
MDR Text Key5720506
Report Number1314492-2015-03536
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,Company Representative
Reporter Occupation Biomedical Engineer
Remedial Action Repair
Type of Report Initial
Report Date 02/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2015
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 Manufacturer02/02/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/16/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2011
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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