MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR; ICP MONITORING

Catalog Number CAM02

Device Problems Bent (1059); High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Four patients presented with very high intracranial pressure (icp) readings (60-80mmhg) post implantation.These reading were not accepted by the neurosurgeons.The patients were sent for ct scan/magnetic resonance imaging and appeared to have "plenty of space".Upon removal, one of the 110-4b catheters was found to be "bent".The issue increased the time for following patient pressure.Additional information received on 24jan2017 with the following: the monitor was changed multiple times for the four patients who had the catheter placed due to head trauma but the icp reading was still elevated.No patient injury was reported.As a precaution, all 8 of the customer's cam02 monitors will be sent to the manufacturer for evaluation.Linked to mfg.Report numbers: 2023988-2017-00005, 2023988-2017-00006, 2023988-2017-00007, 2023988-2017-00008, 3006697299-2017-00018, 3006697299-2017-00019, 3006697299-2017-00020, 3006697299-2017-00024, 3006697299-2017-00022, 3006697299-2017-00023, 3006697299-2017-00025.

Manufacturer Narrative

Investigation completed 3/13/17.Method: -dhr review, -trend analysis, - failure analysis.The dhr review was completed for cam02 monitor serial number (b)(4).The dhr review verified no anomalies that could be associated with the complaint were observed.All the functionality tests were carried out accordingly and all results of the tests were recorded as within specification prior to the cam02 monitor being released.A review of the customer complaints was competed using the following key words ¿reading high values¿ in the search criteria.The review encompassed dates 27-jan-16 to 22-feb -17; 11 complaints which contained the search criteria.Rate of occurrence: during the time period ¿jan 16 to feb 17¿, the global product usage for cam02 monitors combined was calculated as 26,866 usages.The quantity of complaints in the complaint review (11) can therefore be calculated as 0.04% (4 x 10-4) (occasional) of procedures.The failure analysis evaluation verified the complaint as valid; the cause was identified as the customer¿s pmio-mpm cable being defective and required to be replaced.The cam02 monitor was verified as performing to specification.The cam02 monitor was functionally tested.The results were reviewed as part of this investigation; all the functionality tests were carried out accordingly and all results of the tests were recorded as within specification.The evaluation verified the complaint as valid; the cable and the monitor were evaluated together as a system.The nature of the cam02 monitor system results in complaints being reported by the customer as failure symptoms for the cam02 monitor.The reported symptom is not indicative of the actual failure.Conclusion: the evaluation verified the complaint as valid; the cause was identified as the customer¿s pmio-mpm cable being defective and thus resulted in the complaint incident.Based on failure analysis investigation no corrective actions are deemed necessary for cam02 monitors.Future incidents of this nature will be monitored and documented for recurrence and trending purposes.

• Brand Name: INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
• Type of Device: ICP MONITORING
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6300458
• MDR Text Key: 66683644
• Report Number: 3006697299-2017-00021
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K121573
• 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: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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