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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.

 
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Brand NameSPECTRUM INFUSION PUMP
Type of DeviceINFUSION PUMP
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEDINA
711 park ave
medina NY 14103
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10216157
MDR Text Key198088859
Report Number1314492-2020-02091
Device Sequence Number1
Product Code FRN
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK133801
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/20/2020
1 Device Was Involved in the Event
0 PatientS WERE 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
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2020
Is this a Reprocessed and Reused Single-Use Device? No

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