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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; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE Back to Search Results
Model Number CARTRIDGE
Device Problem Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Blood Loss (2597)
Event Date 06/20/2016
Event Type  Injury  
Event Description
A patient had a blood loss during a dialysis treatment when the patient reportedly pulled the venous needle from the av fistula.The patient had a cardiac arrest and was successfully resuscitated and transferred to the icu.The patient was transfused with blood.The dialysis nurse manager estimated that the phoenix machine continued to run for a minute at a bfr of 400 ml/min before it alarmed.The phoenix machine was inspected and operating within manufacturer's specification with audible alarms.The machine was returned to service following a simulated patient run.The cartridge blood tubing was discarded and not available for inspection.
 
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Brand Name
CARTRIDGE
Type of Device
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Manufacturer (Section D)
GAMBRO RENAL PRODUCTS S.A. DE C.V.
blvd. pacifico no. 10014
parque industrial pacifico
tijuana
MX 
Manufacturer Contact
luz del sol rodriguez
blvd. pacifico no. 10014
parque industrial pacifico
tijuana 
MX  
6646266700
MDR Report Key5797116
MDR Text Key49620409
Report Number8030638-2016-00007
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 07/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberCARTRIDGE
Device Catalogue Number101025
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/14/2016
Distributor Facility Aware Date06/21/2016
Event Location Dialysis Unit
Date Report to Manufacturer06/21/2016
Initial Date Manufacturer Received 06/21/2016
Initial Date FDA Received07/14/2016
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
PHOENIX MACHINE
Patient Outcome(s) Required Intervention;
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