SYNCHROMED II

MDR report key: 2882719 · Received December 20, 2012

Report

Report Number: 3004209178-2012-12137
Event Type: Injury
Date Received: December 20, 2012
Report Date: November 20, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT ID, 8840 LOT# SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID, 8709SC LOT# SERIAL# (B)(4), PRODUCT TYPE CATHETER PRODUCT ID, 8598A LOT# SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PROGRAMMING ERROR WAS PERFORMED BY A HEALTHCARE PROFESSIONAL. THE TYPE OF DRUG IN THE PATIENT'S PUMP WAS BEING CHANGED, AND A BRIDGE BOLUS WAS NOT PERFORMED AT THE TIME OF THE CHANGE TO AN INTERMEDIARY SALINE. CONSEQUENTLY, WHEN THE NEW DRUG (PRIALT) WAS MADE AVAILABLE IN THE PUMP, AND A PRIMING BOLUS WAS PERFORMED, THE PATIENT RECEIVED A "SIGNIFICANT BOLUS OF HIS OLD DRUG COMBINATION THAT HAD NOT YET CLEARED HIS CATHETER". THE PATIENT EXPERIENCED AN INABILITY TO USE HIS LEGS, AND HIS BLOOD PRESSURE DROPPED "DRAMATICALLY". THE CLINIC BROUGHT THE PATIENT TO THE ER WHERE HE WAS GIVEN INTRAVENOUS FLUIDS AND HE FULLY RECOVERED. THE OLD DRUGS USED WITHIN THE PUMP WERE DILAUDID, BUPIVACAINE, AND CLONIDINE. THE NEW DRUG USED WITHIN THE PUMP WAS PRIALT. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS SUBMISSION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MDT PUERTO RICO OPERATIONS CO	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention