MAUDE Adverse Event Report: RAYNHAM CERELINK ICP PROBE BASIC KIT; ICP MICRSOSENSORS - CERELINK

Catalog Number 826850

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that following the first failed attempt with the cerelink sensor and monitor it was agreed that it should be reattempted with another monitor and sensor from a different lot.This was undertaken in recovery under sterile conditions.After implantation, it appeared to be working for about 20 minutes with an icp reading occurring and waveforms being produced.Then just like previously the icp reading started dropping to -50 and then produced an error message saying ¿sensor or extension cable failure! disconnect and replace cable or sensor.¿ after trying multiple cables and monitors again we found the error message continued to be produced.The decision was made by the surgeon to remove the 2nd faulty sensor and discharge the patient home after 2 failed attempts and 2 days in hospital.Moving forwards, we will be looking at using a ge monitor in conjunction with icp express and microsensor next week where the patient will undergo another operation under general anaesthetic.

Manufacturer Narrative

Udi: (b)(4).The microsensor was received for evaluation: dhr - conformed to the specifications when released to stock.Failure analysis - based on the supplier analysis and investigation, the issue of the complaint has not been confirmed: the device passed all testing performed.Root cause - 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 defect reported by the customer could be due to excessive pressure applied to product.

• Brand Name: CERELINK ICP PROBE BASIC KIT
• Type of Device: ICP MICRSOSENSORS - CERELINK
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8937258
• MDR Text Key: 156398890
• Report Number: 1226348-2019-00381
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K173192
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 826850
• Device Lot Number: 3303134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1