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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 H938740
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an unspecified quantity of exactamix 2000 ml eva tpn bags were damaged.The damaged bags were further described as, ¿the bags splitting at the seam just below the hole at the top of the bag where it hangs on an iv pole¿.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
D4: expiration date: remove 08/31/2026 as previously reported and replace with ni.H4: device manufacture date: remove 11/14/2023 as previously reported.H4: the lot was manufactured september 18, 2023 - september 19, 2023.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
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 Key18412607
MDR Text Key331541715
Report Number1416980-2023-06807
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477244
UDI-Public(01)00085412477244
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/29/2024
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 NumberH938740
Device Lot Number60497418
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/01/2023
Initial Date FDA Received12/28/2023
Supplement Dates Manufacturer Received01/18/2024
Supplement Dates FDA Received01/29/2024
Date Device Manufactured11/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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