Description of Event or Problem · 0
PT'S WIFE REPORTED THAT THE PT'S VYALEV PUMP IS NOT WORKING PROPERLY. PT HAS MISSED SOME DOSES AND IS NOT SURE HOW LONG HIS PUMP HAS BEEN OFF. ALSO CALLED VYALEV NURSE AMBASSADOR, WHO TRIED TROUBLESHOOTING WITH PT OVER THE PHONE, BUT WAS NOT ABLE TO RESOLVE THE ISSUE. WIFE STATED THAT THE NURSE SAID THAT SHE WILL REPORT IT TO THE MANUFACTURER, BUT ALSO ADVISED TO CALL (B)(6) SO THAT WE CAN SEND OUT A NEW PUMP FOR PT. WIFE REPORTS THAT THE PUMP WILL INTERMITTENTLY SHOW AN ERROR MESSAGE, "HAS SYRINGE BEEN REMOVED?" STATES THAT WHEN THIS MESSAGE SHOWS UP, THE PUMP WILL AUTOMATICALLY SHUT OFF IF NO SELECTION IS MADE, BUT NO ALARM SOUNDS TO NOTIFY THEM THAT THE MESSAGE HAS APPEARED. WIFE STATES THAT THIS MESSAGE TYPICALLY POPULATES AFTER THEY SWITCH OUT BATTERIES, BUT THIS MESSAGE HAS SHOWN UP WHILE PT IS ACTIVELY WEARING THE PUMP AND NOT ACTIVELY CHANGING THE BATTERY. INDICATION: PARKINSON'S DISEASE WITH DYSKINESIA, WITH FLUCTUATIONS. THIS ERROR MESSAGE HAS BEEN SHOWING MORE THAN 3 TIMES THE PAST 2 DAYS AND IT IS NOT A BATTERY ISSUE BECAUSE PT'S WIFE STATED THAT THEY USE A NEW BATTERY EVERYDAY. PT'S WIFE IS CONCERNED THAT HER HUSBAND IS NOT GETTING ALL HIS MEDICATION SINCE THE PUMP WILL SHUT OFF WITHOUT NOTICE WHENEVER THE MESSAGE POPULATES. PER PT'S WIFE, THE NURSE ALSO HAD THEM TURN ON AND OFF THE PUMP, BUT THAT DID NOT SEEM TO RESOLVE THE ISSUE. PT NEEDS A NEW PUMP. PT'S WIFE STATES THAT PT'S DOSE HAS ALSO CHANGED SINCE WE LAST SENT OUT THE PUMP, SO WE WILL NEED TO REACH OUT TO MD FOR A NEW UPDATED PRESCRIPTION. NO MISSED DOSE OR ADVERSE EVENT REPORTED; AVAILABLE FOR RETURN. NO FURTHER INFORMATION.