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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 2C2118K
Device Problem Disconnection (1171)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Event date: the customer reported "the issue started approximately in may".Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the top (elastomeric cap) of 10 units of ce intermate sv (small volume) were "coming off".This was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d10, h3, h4 and h6.H4: device manufactured between october 08, 2019 to october 09, 2019.H10: ten (10) devices were received for evaluation.A visual inspection was done which observed blue coil cap had detached from their housing (small volume cover).No signs of malformed housing were observed that could have caused the blue coil cap to detach.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 Key10321147
MDR Text Key200256726
Report Number1416980-2020-04280
Device Sequence Number1
Product Code FRN
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 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C2118K
Device Lot Number19K044
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2020
Date Manufacturer Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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