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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC
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BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C2702K
Device Problem Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2024
Event Type  malfunction  
Event Description
It was reported that the balloon of a small volume infusor burst during a second round of injection when filling the device.The device was initially injected with drugs using a 50cc syringe.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Additional information: d4, h3, h4, h6, h10 h4: the lot was manufactured between april 3, 2023 - april 5, 2023.H10: the actual device was received for evaluation.Visual inspection was performed which observed that the bladder has been ruptured.The ruptured bladder was examined for signs of abnormality; no signs of abnormality were observed.The reported condition was verified.The cause of the condition could not be determined; however, a possible cause may be due to inherent variation in the material from manufacturing, as bladders are manufactured with rubber.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
INFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - IRVINE
17511 armstrong avenue
building 3
irvine CA 92614
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key18680229
MDR Text Key335077460
Report Number1416980-2024-00458
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C2702K
Device Lot Number23D002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2024
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NA.
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