MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,03 report with the FDA on 2014-09-09 for LEKSELL GAMMA KNIFE 24001 manufactured by Elekta Instrument Ab.
[4829187]
The following information was received from (b)(4) current event notification report: "on (b)(4) 2014 the agency was notified by the licensee that a patient had received a portion of a treatment intended for a different patient. The licensee's risk compliance office (rco) stated two patients had arrived for treatment. Both patients were female of similar size. Both were to receive treatment to the brain, one patient to the right side and the other to the left side. The treatment head frame had been placed on both patients. It was decided that patient two would be treated first. This information was not provided to the individual entering the program into the treatment system so the program for patient one was entered into the treatment system. Patient two was placed on the treatment table and the treatment started. About two minutes into the treatment, a physician reviewing the treatment realized the wrong plan for the patient was being used and halted the treatment. " "the licensee determined the patient received 3. 7 gray to 0. 5 cc of brain tissue during the treatment. The patient and the patient's physician were notified of the error. The rco stated the patient's doctor evaluated the event and stated the patient should not experience any adverse effects from the exposure. The patient was later treated using the correct treatment plan. " "the licensee has implemented several corrective actions as a result of the event. They include adding a second time out prior to treatment and requiring multiple staff to identify. "
Patient Sequence No: 1, Text Type: D, B5
[12224692]
The equipment used in this case was a leksell gamma knife? 4c. It has no features for recognizing the patient under treatment. Instead it is clarified for the user that procedures shall be set up to assure that the actual patient is the one in the treatment plan. The following can be read in the instructions for use: "prepare a checklist that is followed during each procedure. Some steps that should be included are outlined below. 1... 2 check that the patient id stated in the treatment plan is correct and corresponds to the actual patient.. 3... " the event, when the wrong patient was treated, was therefore a user error and not caused by a malfunction in the product. No further actions intended by the manufacturer. This is the manufacturer's final report. (b)(4) notification report: - user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612186-2014-00007 |
| MDR Report Key | 4071955 |
| Report Source | 00,03 |
| Date Received | 2014-09-09 |
| Date of Report | 2014-09-09 |
| Date of Event | 2014-07-28 |
| Date Mfgr Received | 2014-08-11 |
| Date Added to Maude | 2014-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | LINAC HOUSE FLEMING WAY |
| Manufacturer City | CRAWLEY, WEST SUSSEX RH109RR |
| Manufacturer Country | UK |
| Manufacturer Postal | RH10 9RR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEKSELL GAMMA KNIFE |
| Generic Name | SYSTEM, RADIATION THERAPY, RADIONUCLIDE |
| Product Code | IWB |
| Date Received | 2014-09-09 |
| Model Number | 24001 |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELEKTA INSTRUMENT AB |
| Manufacturer Address | P.O. BOX 7593 STOCKHOLM, SE-103 9 SW SE-103 93 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-09 |