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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD WITH AND WITHOUT ANTI-REGURGITATION VALVE

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BAXTER HEALTHCARE - TIJUANA BAJA CARTRIDGE; SET, TUBING, BLOOD WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Catalog Number 101025
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during patient treatment with gambro cartridge dn prime line, the customer observed that the arterial pressure pod was cracked.No external blood leakage was reported there was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
A batch review was conducted and there was no deviation found related to this reported condition during the manufacture of this lot.The actual device was not available for evaluation, however, eight retained samples were evaluated.Visual inspection, burst and leak tests were performed and did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CARTRIDGE
Type of Device
SET, TUBING, BLOOD WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
BAXTER HEALTHCARE - TIJUANA BAJA
tijuana baja california
MDR Report Key7718401
MDR Text Key115394417
Report Number8030638-2018-00011
Device Sequence Number1
Product Code FJK
UDI-Device Identifier07332414007836
UDI-Public(01)07332414007836
Combination Product (y/n)N
PMA/PMN Number
K070414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 08/14/2018
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 Health Professional
Device Expiration Date11/15/2020
Device Catalogue Number101025
Device Lot Number1000182176
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/30/2018
Initial Date FDA Received07/25/2018
Supplement Dates Manufacturer Received08/02/2018
Supplement Dates FDA Received08/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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