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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
Catalog Number 101025
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Blood Loss (2597)
Event Date 05/05/2014
Event Type  Injury  
Event Description
A patient in the icu, post myocardial infarction, experienced worsening of his stage iii ckd and required hendiadys.Approximately two minutes after starting the dialysis treatment, the nurse observed blood leaking from around the venous line connector and tego adapter/connector.The nurse stopped the blood pump and attempted to tighten the connection without success.While the nurse was trying to return the blood, the patient coded and successfully resuscitated.
 
Manufacturer Narrative
The blood tubing set involved in the incident was evaluated and the conclusion is as follow: the venous luer cone from the blood tubing set did not have any cracks.The venous luer locking collar threads had no cracks.Venous luer connector of the blood tubing set are in compliance with the iso standard 594/1 and 594/2.15 unused cartridge blood sets from the reported lot number 1000079632 were inspected for possible physical characteristics that may contributed to loosing connections.The visual inspection made and the leak test completed for the bloodline did not identify any condition outside the product predetermined validated specifications.There are no conditions present in the blood tubing set that may have aid for a loose connection or a leak.Gambro has found no evidence to suggest that any gambro device caused or contributed to this event.Gambro does not regard the submittal of this report as an admission of causation or liability.
 
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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
ramon ruiz
blvd. pacifico no. 10014
parque industrial pacifico
tijuana 
MX  
6646266700
MDR Report Key3848029
MDR Text Key4406090
Report Number8030638-2014-00007
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 06/04/2014
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 Health Professional
Device Expiration Date01/15/2017
Device Catalogue Number101025
Device Lot Number1000079632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2014
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2014
Distributor Facility Aware Date05/05/2014
Device Age4 MO
Event Location Dialysis Center
Date Report to Manufacturer05/05/2014
Initial Date Manufacturer Received 05/05/2014
Initial Date FDA Received06/04/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PHOENIX SN (B)(4) SWV 3.36.02, REVACLEAR,BICART720
Patient Outcome(s) Required Intervention;
Patient Age52 YR
Patient Weight77
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