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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number ASKU
Device Problem Fitting Problem (2183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2018
Event Type  malfunction  
Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the line of a cassette would not connect to the bag.It was further reported that the line kept on turning; it did not tighten.This was noticed before initiating therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
NI
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
ni
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
ni
ni
ni
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8259425
MDR Text Key133462359
Report Number1416980-2019-00143
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other
Type of Report Initial
Report Date 01/17/2019
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 Lay User/Patient
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/20/2018
Initial Date FDA Received01/17/2019
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 N
Patient Sequence Number1
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