FDA.reportPublic FDA data

MAUDE MDR 9908075

MDR report key
9908075
Report number
3004209178-2020-06474
Event key
0
Event type
3
Date of event
2020-03-16
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA WOODWARD CLARK
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNCHROMED IIPUMP, INFUSION, IMPLANTED, PROGRAMMABLEMEDTRONIC PUERTO RICO OPERATIONS CO.LKK8637-208637-20* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WHO WAS RECEIVING HEPARIN WITH A CONCENTRATION AND DOSE OF 1 ML/ML AT 0.7 UNITS/DAY AND FLOXURIDINE WITH A CONCENTRATION AND DOSE OF 1 ML/ML AT 1 ML/DAY VIA IMPLANTABLE DRUG DELIVERY PUMP. IT WAS REPORTED THAT THE PATIENT HAD A HEPATIC ARTERY INFUSION (HAI) REFILL ON (B)(6) 2020 AND CAME BACK FOR ANOTHER REFILL ON (B)(6) 2020. WHEN THE HCP INTERROGATED THE PUMP IT WAS SHOWING THE PUMP WAS IN STOPPED PUMP MODE AND THE TUBE SET ALARM OCCURRED ON (B)(6) 2020. THEY WERE UNSURE IF THE PATIENT HEARD THE PUMP ALARMING. THEY CHECKED THE PUMP LOGS AND THE LOGS SHOWED THE UPDATE ON (B)(6) 2020 BUT THERE WAS NOT A SUCCESSFUL UPDATE (PUMP RESTARTED DUE TO RESTART COMMAND). DISCUSSED INCOMPLETE TELEMETRY, INTERFERENCE, MOVEMENT OF TELE HEAD. HCP STATED THAT TODAY ((B)(6) 2020) THEY WERE CHANGING TO HEPARINIZED SALINE. DISCUSSED THAT THE PATIENT HAD NOT RECEIVED THE FLOXURIDINE POST (B)(6) 2020 REFILL. DISCUSSED CONTACTING THE PHYSICIAN TO UPDATE THEM ON THE SITUATION. DISCUSSED CONTACTING THE LOCAL MDT REP FOR INSERVICING ON PROGRAMMING AND USE OF THE PROGRAMMER 8840. DISCUSSED NEW TABLET. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED.