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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC

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BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Catalog Number 2C1075KJP
Device Problem Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Date 12/12/2017
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a two day infusor had a ¿deflated balloon.¿ this occurred before use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
The lot was manufactured between (b)(4) 2013 ¿ (b)(4) 2013.The device was received for evaluation.A visual inspection was performed and it was noted that the foil packaging around the device was slightly deflated.Further inspection revealed that there was a tiny hole located on the foil packaging.The reported condition was verified.The cause of the reported 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
INFUSOR
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
BAXTER HEALTHCARE - IRVINE
irvine CA
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 Key7174289
MDR Text Key96815967
Report Number1416980-2017-10280
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K062457
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 02/09/2018
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 Expiration Date05/01/2018
Device Catalogue Number2C1075KJP
Device Lot Number13E053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2017
Initial Date FDA Received01/08/2018
Supplement Dates Manufacturer Received01/22/2018
Supplement Dates FDA Received02/09/2018
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 N
Patient Sequence Number1
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