SYNCHROMED II

MDR report key: 2810306 · Received October 31, 2012

Report

Report Number: 3004209178-2012-09765
Event Type: Injury
Date Received: October 31, 2012
Report Date: October 4, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

CATEHTER MODEL: 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), EXPLANTED: UNK (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT WAS ELDERLY AND COULD NO LONGER TOLERATE INTRATHECAL MEDICATIONS; HENCE THEY WANTED TO TURN THE PUMP OFF. IT WAS ADDED THAT THE HEALTHCARE PROVIDER (HCP) HAD ATTEMPTED TO FILL PUMP TWICE BUT PATIENT HAD "ENDED UP IN THE ICU". PATIENT WAS REFILLED ON (B)(6) 2012 WHEN SALINE WAS PROGRAMMED AT 0.05 ML/DAY. IT WAS ALSO ADDED THAT THE PUMP HAD BEEN ALARMING SINCE (B)(6) 2012 AND THEY HAD SEEN THE TUBE SET WARNING SCREEN ON THE 8840-PHYSICIAN PROGRAMMER. IT WAS ALSO REPORTED THAT THE PUMP HAD BEEN STOPPED PREVIOUSLY. ADDITIONAL INFORMATION RECEIVED FROM THE HCP CLARIFIED THAT THE EVENT WAS DUE TO DRUG EFFECTS. PATIENT HAD EXPERIENCED PROFOUND SEDATION AND RESPIRATORY DEPRESSION EVEN WITH MICRODOSING. PATIENT WAS HOSPITALIZED. ON (B)(6) 2012 DOSE ADJUSTMENT WAS DONE AND PATIENT STILL CONTINUED TO HAVE SEDATION WITH 0.1 MG/D HYDROMORPHONE. CURRENTLY THE PUMP WAS FILLED WITH SALINE AT MIN DAILY RATE. PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-20

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R