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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUR IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL
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BAXTER HEALTHCARE CORPORATION TUR IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL Back to Search Results
Catalog Number 2C4005
Device Problems Improper Flow or Infusion (2954); Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/04/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(6).(b)(4).The device was received and is currently awaiting evaluation completion.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported ¿foam and small air bubbles¿ were observed in a y-type tur irrigation set during a ramucirumab infusion this would result in air in pump alarms via a spectrum pump.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
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
TUR IRRIGATION SET
Type of Device
SYSTEM, IRRIGATION, UROLOGICAL
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10631366
MDR Text Key209954455
Report Number1416980-2020-06196
Device Sequence Number1
Product Code LJH
UDI-Device Identifier00085412000978
UDI-Public(01)00085412000978
Combination Product (y/n)Y
PMA/PMN Number
K960787
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C4005
Device Lot NumberR20D16020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Date Manufacturer Received11/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RAMUCIRUMAB; SPECTRUM INFUSION IQ PUMP
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