MAUDE Adverse Event Report: ICU MEDICAL TRIOX-PICC; CATHETER

Model Number	52516-15
Medical Device Problem Code	Calibration Error (1078)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot review: no exception documents cited in work order.
Event or Problem Description
Optical module of catheter was not reading svo2.The cco box was changed out but same issues occurred.Facility reports that there was a critical delay in therapy and medical intervention was required.No other information was provided.
Additional Manufacturer Narrative
Lot review: no exception documents cited in work order.Visual analysis: received one used 52516-15.There is residual blood observed but was flushed out of the catheter during decontamination.The proximal tubing is occluded.No visual anomalies.Functional analysis: initial calibration of the returned device was successful.It was observed that crosstalk between the two optic fibers was occurring.Crosstalk could possibly lead to inaccurate svo2 readings.Summary conclusion: the report of svo2 not reading could not be replicated.No defect was found and the heating coil was working within specifications.
Event or Problem Description
Optical module of catheter was not reading svo2.The cco box was changed out but same issues occurred.Facility reports that there was a critical delay in therapy and medical intervention was required.No other information was provided.

• Brand Name: TRIOX-PICC
• Common Device Name: CATHETER
• Manufacturer (Section D): ICU MEDICAL; 4455 atherton drive; salt lake city UT 84117
• MDR Report Key: 7095041
• Report Number: 2025816-2017-00251
• Device Sequence Number: 1182881
• Product Code: DQE
• UDI-Device Identifier: 00840619060305
• UDI-Public: 840619060305
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2018
• Device Model Number: 52516-15
• Device Catalogue Number: 52516-15
• Device Lot Number: 3418977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1