MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LTD. CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,; N/A

Catalog Number CAM01

Device Problems No Device Output (1435); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device involved in the reported incident is expected to be returned for evaluation.An investigation has been initiated based upon the reported information.

Event Description

The camino catheter that had been in a patient had came out of place ( it was not known how it happened).There was no patient injury reported.However, they replaced the catheter with a new one but the monitor still would not give them any readings, instead they were just being told the catheter was not connected properly.The staff then tried to use a different monitor and this time it would not go past the start screen.The monitors were at the hospital on a long term loan basis.The event did not lead to an increase of surgery.Additional information was requested and on (b)(6) 2016, the following was provided: the customer does not have the catheter to return.They used a competitor product (raumedic) to continue monitoring the patient.Linked to mfg.Report number: 2023988-2016-00024 (camino catheter) and 3006697299-2016-00150 (1st camino monitor used).

Manufacturer Narrative

Integra has completed their internal investigation on 08/10/2016.The investigation included: methods: evaluation of actual device; review of device history records.Review of complaint history.Results: evaluation of device: the cam01 monitor serial number (b)(4) and the following accessories: pac1 cable (sn: (b)(4)) and mains lead eu / uk were returned for evaluation.During investigation, it was observed that the ict cable had a cut resulting in the cam01 monitor failure to display any temperature information.This failure can be concluded as a connection failure.Also, the battery has been expired.The pac1 cable received was found to be functioning.As part of the repair, the battery and the ict cable were replaced.The cam01 monitor was fully calibrated and functionally tested to specifications prior been returned to customer.All results of the functionality tests for cam01 monitor serial number (b)(4) were recorded as within specification and final release checks were performed satisfactory prior to the monitor been released.Service history: 09.04.2014, 12.12.2013, 06.03.2013.The reviewed service history documentation for cam01 monitor serial number (b)(4) has identified no impact on complaint incident.The dhr review has been deemed satisfactory.Trending analysis was completed by the root cause identified in the failure analysis investigation.Based on the complaint description, the complaint incident is trended as a failure of the cam01 monitor to function properly, thus device not working.A minimum of 12-month review of cam01 monitor customer complaints was completed in complaint system using the following key words ¿device not working¿ and a root cause ¿connection failure (cut ict cable) & expired battery¿ in the search criteria.This review encompassed from dates 20-jun-2015 to 03-aug-2016.A total of (b)(4) complaints were reviewed of which (b)(4) complaints contained the search criteria.The analysis of the complaint investigations and root cause reports has concluded this complaint is the 1st identified complaint for the reported failure with the root cause identified as connection failure (cut ict cable) & expired battery and 3rd identified complaint related to root cause battery failure.No trend has been identified.The failure analysis investigation has concluded the cause of the cam01 monitor not working was due to the cut ict cable which resulted in the failure of the cam01 monitor to display any temperature information.This failure can be concluded as a connection failure.Also, the battery has been expired.Therefore, the root cause is connection failure (cut ict cable) & expired battery.

• Brand Name: CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES (IRELAND) LTD.; sragh tullamore, co. offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5764776
• MDR Text Key: 49390198
• Report Number: 3006697299-2016-00152
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

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 Catalogue Number: CAM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2016
• Initial Date FDA Received: 07/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1