MAUDE Adverse Event Report: GAMBRO RENAL PRODUCTS S.A. DE C.V. CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

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.

• 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 Key: 3848029
• MDR Text Key: 4406090
• Report Number: 8030638-2014-00007
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070414
• Number of Events Reported: 1
• 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 Date: 01/15/2017
• Device Catalogue Number: 101025
• Device Lot Number: 1000079632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2014
• Distributor Facility Aware Date: 05/05/2014
• Device Age: 4 MO
• Event Location: Dialysis Center
• Date Report to Manufacturer: 05/05/2014
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PHOENIX SN (B)(4) SWV 3.36.02, REVACLEAR,BICART720
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Weight: 77