MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERELINK ICP EXT CABLE; CERELINK - CABLES

Model Number	826845
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is 3 of 3 reports linked to mfg report numbers: 3013886523-2022-00204, 3014334038-2022-00106.A facility reported a cerelink sensor (unknown id) was placed in the right frontal lobe via a bolt (metal skull bolt kit) of a patient with traumatic brain injury (tbi) on (b)(6) 2022 at 21:00.After 24 hours of admission due to the icp kept spiking the patient had a left frontoparietal decompressive hemicraniectomy performed.On (b)(6) 2022 (morning) the icp was ~12mmhg to 15mmhg most of the day with occasional spiking ~20mmhg (not sustained).Later, the nurse noticed the icp was drifting down to ~2-3mmhg with a poor waveform.The patient was scheduled for a post-op ct.Prior to ct, the icp was 2mmhg to 3mmhg with a poor waveform; but upon arrival back to the icu, the error code appeared on the cerelink icp monitor.During transport to the ct scanner, the nurse did not take the cerelink monitor.She disconnected the icp extension cable from the microsensor.Troubleshooting steps they took ¿ all were unsuccessful: rebooted the cerelink = (error code remained).Turned the cerelink off x 5 minutes ¿ then turned back on = (error code remained).Changed out icp extension cable = (error code remained).Changed cerelink monitor ¿ (error code remained).Physician's decision was to remove it and not replace the icp.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The cerelink cable (unknown id) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.A corrective and preventive action (capa) was opened to investigate the failure mode of "out of range reading".The root cause investigation will be captured under that action.

• Brand Name: CERELINK ICP EXT CABLE
• Common Device Name: CERELINK - CABLES
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• Manufacturer (Section G): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; ch-2400; le locle ; SZ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 14458989
• Report Number: 3013886523-2022-00205
• Device Sequence Number: 11933659
• Product Code: GWM
• UDI-Device Identifier: 10381780520665
• UDI-Public: 10381780520665
• Combination Product (Y/N): N
• PMA/510(K) Number: K210993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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 Model Number: 826845
• Device Catalogue Number: 826845
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 12/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown