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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH GAMBRO BLOOD SET CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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GAMBRO DIALYSATOREN GMBH GAMBRO BLOOD SET CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Lot Number (10) 1000280259
Device Problems Nonstandard Device (1420); Device Dislodged or Dislocated (2923)
Patient Problem Insufficient Information (4580)
Event Date 06/01/2021
Event Type  Injury  
Event Description
S- gambro blood line cartridge for dialysis.The arterial line dislodged from the in-line needle access port.B- this has happened in the past and a recall was issued about 8-12 months ago.Failure has occurred in the same place as before.A- this could cause patient injury/death.R- removed all like lot number from use immediately, send high alert email thru national va.Dialysis managers email to alert.File jpsr and contact gambro.Fda safety report id # (b)(4).
 
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Brand Name
GAMBRO BLOOD SET CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
GAMBRO DIALYSATOREN GMBH
MDR Report Key11929979
MDR Text Key254488561
Report NumberMW5101688
Device Sequence Number1
Product Code FJK
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/01/2021
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 Date12/15/2023
Device Lot Number(10) 1000280259
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/02/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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