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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 2C1009K
Device Problems Filling Problem (1233); Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Event Description
It was reported that an english-chinese infusor lv (large volume) ¿had an overinfusion problem¿.The issue was further described as ¿the fluid was found to flow too fast¿.This was identified during filling prior to connecting to the patient.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
H10: the actual device was received for evaluation.A visual inspection was performed using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and found to be within the product specification range.The reported condition was not verified.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 
2242702068
MDR Report Key12762942
MDR Text Key280545121
Report Number1416980-2021-06631
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00085412022529
UDI-Public(01)00085412022529
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/09/2021
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 Number2C1009K
Device Lot Number21B004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2021
Initial Date FDA Received11/07/2021
Supplement Dates Manufacturer Received12/01/2021
Supplement Dates FDA Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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