MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERELINK ICP PROBE BASIC KIT; ICP MICRSOSENSORS - CERELINK

Catalog Number 826850

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported no signal of the directlink module: the directlink was placed in the operative room and zeroed successfully to the ge monitor.The directlink was disconnected from the ge monitor and connected to the philips intelliuve mx800 in the icu and reconnecting procedures were followed.The signal was detected, and the measurement was ok.The patient was taken to a ct scan with the extension of the philips monitor (no splitter but directly with the philips cable).Upon return to the icu the directlink was reconnected to the patient monitor which displayed a signal of ¿?¿.The cables were all changed from the bedside monitor to the directlink and from the directlink to the sensor but nothing happened.After 1 hour the monitoring restarted properly and was compatible with the patient status reading 20mmhg.

Manufacturer Narrative

Udi : (b)(4).The microsensor was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer 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.

Event Description

N/a.

Manufacturer Narrative

Udi : (b)(4).The microsensor was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.Failure analysis - based on the analysis and investigation, the issue of the complaint was not confirmed: film over sensor and adhesive area that is not part of the manufacturing process.Unable to balance sensor due to film residue; removed film residue; able to balance sensor.Received catheter with sutures and catheter tied in a loop, tape wrapped around part of the catheter and connector and dirty.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.The root cause of the issue reported by customer could not be determined as the device worked correctly.However, the possible root cause of the problem stated reported by the customer could be user related (film residue).

Event Description

N/a.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• Type of Device: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES SWITZERLAND SAR; rue girardet 29; rue girardet 29; le locle ; SZ
• MDR Report Key: 10327095
• MDR Text Key: 200856646
• Report Number: 3013886523-2020-00009
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K152670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/08/2020

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: 11/30/2020
• Device Catalogue Number: 826850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 09/04/2020; 11/03/2020
• Supplement Dates FDA Received: 09/22/2020; 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1