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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPECTRUM INFUSION PUMP
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BAXTER HEALTHCARE CORPORATION SPECTRUM INFUSION PUMP Back to Search Results
Catalog Number 35700BAX2
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a spectrum pump had a blank screen.There was no known patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Baxter received and evaluated the device.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A service history review revealed the blank screen was a repeat service event.All service actions were completed during the last service cycle.The reported condition was verified.The device was found out of specification in relation to the reported blank screen, which was reproduced during evaluation.The cause was determined to be a failing display.The display was replaced to correct this condition.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
SPECTRUM INFUSION PUMP
Type of Device
INFUSION PUMP
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10216157
MDR Text Key198088859
Report Number1314492-2020-02091
Device Sequence Number1
Product Code FRN
UDI-Device Identifier00085412498683
UDI-Public(01)00085412498683
Combination Product (y/n)Y
PMA/PMN Number
K133801
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 07/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number35700BAX2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2020
Date Manufacturer Received07/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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