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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS, S.A. DE C.V. CARTRIDGE BLOOD SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
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GAMBRO RENAL PRODUCTS, S.A. DE C.V. CARTRIDGE BLOOD SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number 101025
Device Problems Break (1069); Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/02/2019
Event Type  malfunction  
Event Description
After increasing blood flow rates on dialysis to the ordered flow of 350, the dialysis rn noticed that the arterial pressures were still reading 0.When the nurse and team leader went to examine the set up, it was noted that the back of the arterial chamber was cracked and broken.There was no obvious blood leaking.Patient's blood was not returned.The set up was changed.New tubing and cassette with normal pressures.
 
Event Description
After increasing blood flow rates on dialysis to the ordered flow of 350, the dialysis rn noticed that the arterial pressures were still reading 0.When the nurse and team leader went to examine the set up, it was noted that the back of the arterial chamber was cracked and broken.There was no obvious blood leaking.Patient's blood was not returned.The set up was changed.New tubing and cassette with normal pressures.
 
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Brand Name
CARTRIDGE BLOOD SET
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS, S.A. DE C.V.
one baxter parkway
deerfield IL 60015
MDR Report Key8490796
MDR Text Key141172364
Report Number8490796
Device Sequence Number1
Product Code FJK
UDI-Device Identifier07332414007836
UDI-Public(01)07332414007836(10)1000211724
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101025
Device Catalogue Number101025
Device Lot Number1000211724
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/04/2019
Event Location Hospital
Date Report to Manufacturer04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age22630 DA
Patient Weight44
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