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

Model Number 50328-08

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

Findings: as of the date of this submission the involved catheter device has not been returned for analysis and confirmation.The dfu provides specific instructions for pre-testing/set-up and handling instructions.The catheter was successfully pre-tested with no functional issues or performance abnormalities 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.

Event Description

Complaint received reporting loss of svo2 readings with use of one 50328-08 8f triox svo2 pa catheter.It was reported that ".Opti cath did not read svo2 immediately post op despite all appropriate troubleshooting and cable switch out.The staff was forced to draw svo2 gasses every four hours for three days since the catheter didn't read svo2.".The catheter device was pre-tested prior to placement with no issues detected at that time.There were no reported adverse patient consequences.

Manufacturer Narrative

Device return: one used 50328-08 8f triox svo2 pa catheter w/ 8.5f contamination shield.Engineering testing and analysis: the returned 50328-08 catheter was tested per the applicable specifications including fiber optic and coupler inspection.The results recorded the catheter did not meet specifications, light did not pass through both the sending or return fiber.Additionally the investigation report described additional fiber optic component damages as evidenced by the break/separation of the fiber optic from the catheter connector tips.The 50328-08 catheter was dissected and the components evaluated.The report documented numerous breaks, in the fiber optic in proximity to the 40, 60, 75 108 cm locations.Breaks were also observed at the catheter lumen junction and the thermistor and fiber optic junction locations.The report notes these types of damages are consistent with excessive tension force, sharp bends or excessive physical impact shocks.The dfu provides specific instructions for pre-testing/set-up and handling instructions.The catheter was successfully pre-tested with no functional issues or performance abnormalities 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.(b)(4).Findings: engineering testing and analysis of the returned 50328-08 catheter confirmed the reported product issue.The root cause(s) were determined to be a result of extensive component/fiber optic damages attributable to incorrect usage/technique.

Event Description

Complaint received reporting loss of svo2 readings with use of one 50328-08 8f triox svo2 pa catheter.It was reported that ".Opti cath did not read svo2 immediately post op despite all appropriate troubleshooting and cable switch out.The staff was forced to draw svo2 gasses every four hours for three days since the catheter didn't read svo2.".The catheter device was pre-tested prior to placement with no issues detected at that time.There were no reported adverse patient consequences.This is the mfgers follow up report to provide additional information and the device evaluation results.

• 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: 5333705
• MDR Text Key: 34648662
• Report Number: 2025816-2015-00151
• 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,Followup
• Report Date: 02/08/2016

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: 07/01/2015
• Device Model Number: 50328-08
• Device Catalogue Number: 50328-08
• Device Lot Number: 2899223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1