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

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).

• 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 Key: 11929979
• MDR Text Key: 254488561
• Report Number: MW5101688
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Lot Number: (10) 1000280259
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention