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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP; SET, I.V. FLUID TRANSFER
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BAXTER HEALTHCARE CORPORATION EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938739
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that an exactamix 1000 ml eva (ethylene vinyl acetate) tpn (total parenteral nutrition) bag had foreign material.The solution had a blue suspended substance.This was observed in the pharmacy.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
E1: initial reporter address: (b)(6).E1: initial reporter postal code: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
The lot was manufactured between march 30, 2023 and march 31, 2023.The actual device was received for evaluation.A visual inspection along with magnification noted a small piece of black (not blue) foreign particulate matter (pm) sinking in the solution.The pm appeared to be a piece of corkscrew shaped thread or lint fiber.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
EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
AVAILMED
c. industrial lt. 001 mz. 105
no 20905 int a, col cd ind.
tijuana, baja california 22444
MX   22444
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key18975804
MDR Text Key338567184
Report Number1416980-2024-01332
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477237
UDI-Public(01)00085412477237
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 04/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberH938739
Device Lot Number60448151
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/22/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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