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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERMATE; PUMP, INFUSION

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BAXTER HEALTHCARE CORPORATION INTERMATE; PUMP, INFUSION Back to Search Results
Catalog Number 2C2113K
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a ce intermate lv (large volume) did not infuse at all during a patient infusion.The device was filled with 1g methylprednisolone (solumedrol, non-baxter) and 250ml "g5%" (glucose, non-baxter).There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H4: device manufactured between october 1, 2019 to october 2, 2019.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
INTERMATE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11041162
MDR Text Key222632112
Report Number1416980-2020-07910
Device Sequence Number1
Product Code FRN
UDI-Device Identifier00085412487977
UDI-Public(01)00085412487977
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C2113K
Device Lot Number19K011
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/24/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received01/06/2021
Supplement Dates FDA Received01/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
G5%; SOLUMEDROL
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