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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AC PUMP POWER CORD CSA GREY SYSTEM/DEVICE, PHARMACY COMPOUNDING

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BAXTER HEALTHCARE CORPORATION AC PUMP POWER CORD CSA GREY SYSTEM/DEVICE, PHARMACY COMPOUNDING Back to Search Results
Catalog Number 400100678
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the power cord was observed frayed and the wires were exposed. There was no patient involvement. No additional information is available.
 
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Brand NameAC PUMP POWER CORD CSA GREY
Type of DeviceSYSTEM/DEVICE, PHARMACY COMPOUNDING
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - ENGLEWOOD
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12268103
MDR Text Key264779882
Report Number1416980-2021-04744
Device Sequence Number1
Product Code NEP
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number400100678
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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