MAUDE Adverse Event Report: ICU MEDICAL, INC. 8F TRIOX SVO2 PA CATHETER

Model Number 50328-08

Device Problems Unable to Obtain Readings (1516); Shelf Life Exceeded (1567)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

Device return: one (1) used 50328-08 8f triox svo2 pa catheter ; one (1) used arrow 8f touch contamination shield.The touch contamination shield covered the catheter from approx.The 40cm mark to the 80 cm mark.Engineering evaluations: the returned catheter was tested for calibration, the results recorded the device did not meet specification.The catheter components/fiber optics were analyzed.The report noted that light would not shine through one of the fiber optics.The catheter / components were dissected and evaluated.The results recorded a failure in the fiber optic adjacent to the junction for the thermister wire and the fiber optic.The report also noted indentation observed around the 40 cm mark which appears to have been caused by the 8f touch contamination shield.The 50328-08 directions for use (dfu) identifies this model/size requires use of 8.5 f introducer/contamination shield accessory devices.The dfu provides specific instructions for pre-testing/set-up and handling instructions.Although the catheter device was used four months past the labeled expiration date, the catheter was successfully pre-tested with no functional issues or performance abnomalities detected at that time.The opticath® catheter is a precision optical instrument and must be handled with care.Kinking, excessive manipulation, or grasping with forceps or hemostats can permanently damage the fiberoptics, reducing the transmission of light to and from the blood.Although the exact cause(s) of the product issue are unknown the investigation findings identify usage conditons which appear to have caused and or contributed to the event.

Event Description

Complaint received reporting loss of svo2 readings with use of one 50328-08 8f triox svo2 pa catheter.The initial information received reported that on (b)(6) ".Svo2 did not work post op or subsequent days following surgery.Pa and cvp worked ok.Multiple mixed venous gasses needed to be drawn every 4 hours for 3 days due to this therapy not functioning".The catheter device was pre-tested prior to placement with no issues detected at that time.There were no reported adverse patient consequences.Follow up information reported the device lot# 2887366.A review of the mfg.Lot build; labeling showed this lot was mfg.In 06/2014 with a labeled expiration date of 06/01/2015.(b)(4) units were mfg., tested, inspected and released.There were no exception documents generated during the lot build.

• Brand Name: 8F TRIOX SVO2 PA CATHETER
• Type of Device: 8F TRIOX SVO2 PA CATHETER
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer (Section G): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• Manufacturer Contact: terry scesny ; 4455 atherton drive; salt lake city, UT 84123 ; 8012641400
• MDR Report Key: 5335071
• MDR Text Key: 34761980
• Report Number: 2025816-2015-00150
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K06299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: 50328-08
• Device Catalogue Number: 50328-08
• Device Lot Number: 2887366
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1