CERELINK ICP EXT CABLE
Report
- Report Number
- 3013886523-2022-00127
- Event Type
- Death
- Date Received
- April 6, 2022
- Date of Event
- March 14, 2022
- Report Date
- June 22, 2022
- Manufacturer
- INTEGRA LIFESCIENCES MANSFIELD
- Product Code
- GWM
- UDI-DI
- 10381780520665
- PMA / PMN Number
- K183406
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE CERELINK CABLE WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: THE INTERNAL INSPECTION DID NOT CONFIRM THE REPORTED PROBLEM. THE CABLE WAS TESTED ACCORDING TO PROCEDURE APPLICABLE, AND NO ISSUE WAS IDENTIFIED. THE ROOT CAUSE OF THE ISSUE REPORTED BY CUSTOMER COULD NOT BE DETERMINED AS THE DEVICE WORKED CORRECTLY.
DHR - THE LOT PROVIDED IS THE SUPPLIER LOT NUMBER, NOT INTEGRA. THE REVIEW OF THE HISTORY SUPPLIER LOT 20110210 SHOWED THAT THE POSSIBLE LOT USED IN THIS CASE IS WITHIN THE FOLLOWING INTEGRA LOTS: 5211343, 5261902, 5374642, 5374643, 5374645, 5635025, 5635026. ALL LOTS CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. 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 INAPPROPRIATE TECHNIQUE FOR ASSEMBLY AND USE OF THE DEVICE. FURTHERMORE, AS NOTED IN THE IFU, THE POSSIBLE CAUSES OF MESSAGE "SENSOR OR EXTENSION CABLE FAILURE! DISCONNECT AND REPLACE CABLE OR SENSOR" COULD BE : SYSTEM HAS DETECTED AN ISSUE WITH THE SENSOR OR EXTENSION CABLE, SYSTEM NOT GROUNDED PROPERLY. ELECTRICAL NOISE FROM ADJACENT DEVICES.
2 OF 2 REPORTS. SAME PATIENT, DIFFERENT CABLES. OTHER MFG REPORT NUMBER: 3013886523-2022-00126. A FACILITY REPORTED A MALE PATIENT (MID TO LATE 50'S) HAD A SERIOUS HEAD INJURY AFTER AN ACCIDENT. AN ICP SENSOR KIT WAS IMPLANTED AND CONNECTED TO CERELINK ICP MONITOR ( SN:(B)(4)). THE CERELINK MONITOR DISPLAYED WHAT APPEARED TO BE A RELATIVELY STABLE READING OR AROUND 20MMHG FOR THE FOLLOWING 2 DAYS. PHYSICIAN ATTENDED TO ASSESS THE PATIENT AND DISCOVERED THAT THE METAL SKULL BOLT APPEARED TO HAVE BEEN INCORRECTLY FITTED AND WAS ¿FLAPPING¿ ABOUT. THIS CREATED A CONCERN THAT THE ICP READING WERE POSSIBLY INCORRECT, THEN PROCEEDED TO INSERT A LICOX BOLT AND REINSERT THE ICP SENSOR WHICH THEN READ AN INCREASED ICP OF AROUND 50MMHG +/-. AS THEY PROCEEDED TO MONITOR THE ICP SOMETIME AFTER THIS ¿ THE CERELINK MONITOR DISPLAYED THE ERROR ¿ ¿CONNECTING CABLE MALFUNCTION¿. THEY DECIDED TO CHANGE THE CERELINK MONITOR (TO MONITOR SN:(B)(4)), CABLE (A NEW ONE OF THEIR OWN) AND SENSOR. THE ICP READINGS STAYED VERY HIGH, DISPLAYING THE SAME MESSAGE APPROXIMATELY 20 MINUTES AFTER BEING CHANGED OVER. A NEW CABLE WAS USED AND REMOVED THE FAULTY CABLE. THE PATIENT WAS THEN TAKEN FOR A SCAN AND DURING THIS TIME THE NEW MONITOR DISPLAYED THE SAME MESSAGE OF ¿CONNECTING CABLE MALFUNCTION¿ EVEN WITH ONE OF THEIR OWN NEW CONNECTING CABLE AND SENSOR. EVENTUALLY, THE ERROR MESSAGE ON THE CERELINK HAD DISAPPEARED. THE PATIENT DIED ON (B)(6) 2022; HOWEVER, ACCORDING TO FACILITY "THE FAULTY CABLES WERE NOT THE CAUSE ¿ MORE AN ANNOYANCE DURING A CRITICAL STAGE OF THE PATIENTS TREATMENT".
N/A.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1519294 | CERELINK ICP EXT CABLE | CERELINK - CABLES | GWM | INTEGRA LIFESCIENCES MANSFIELD | 826845 | 10381780520665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Death |