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 Problems Air Embolism (1697); Anxiety (2328)

Event Date 12/11/2013

Event Type  Injury  

Event Description

Within the first 30 minutes of treatment, the nurse visualized foam with micro bubbles in the venous line when she went to administer the patient¿s medication.The patient complained of feeling anxious and short breath, treatment was stopped, and the blood from the extracorporeal circuit was not returned to the patient.The nurse does not recall if the phoenix generated the air in blood alarm or not.The patient was transferred to the hospital and diagnosed with ¿an air embolus which absorbed" the patient was later discharged with no sequelae.Limited clinical information related to the patient has been provided.The customer recently switched from gambro dialyzers to a competitor¿s dialyzer.The priming technique differs between the two dialyzers.Gambro¿s request for an onsite visit by gambro's clinical educator was denied by the director of the dialysis unit.The blood tubing set was discarded and not available for investigation.The phoenix machine was inspected by a gambro technical service representative and within specification.The air in blood sensor was proactively replaced and returned to the manufacturer for analysis.The air in blood sensor was inspected and determined to be operating within specification and as intended.

Manufacturer Narrative

The blood tubing set involved in this incident was discarded and not available for investigation.Fifteen (15) retained blood tubing samples from the same lot number reported ( lot 1000072627) were visually inspected, functional and leak testing was performed and no failures or defects were detected.Gambro has no information to suggest that blood tubing set product caused or contributed to the incident and 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: 3567857
• MDR Text Key: 4216339
• Report Number: 8030638-2014-00001
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/10/2014,12/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: 101025
• Device Lot Number: 1000072627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2014
• Distributor Facility Aware Date: 12/11/2013
• Device Age: 2 MO
• Event Location: Dialysis Center
• Date Report to Manufacturer: 12/11/2013
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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 MACHINE, FRESENIUS OPTIFLUX
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR
• Patient Weight: 65