FDA.reportPublic FDA data

MAUDE MDR 6458079

MDR report key
6458079
Report number
1723533-2017-00004
Event key
0
Event type
3
Date of event
2017-02-01
Date received
2017-04-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR THOMAS ASSANTE
Address
6555 S KENTON ST SUITE 304 CENTENNIAL CO 80111 US
Phone
720-720-7203
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WALKMED 65 ML RESERVOIR BAGRESERVOIR BAGWALKMED INFUSION, LLCBTC204820#IPR-8620816500Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-0401. O

Event Narratives#

N

Patient 1

EXPLANATION FOR DELIQUENCY IN 30 DAY REPORT: IN (B)(6) 2017, WALKMED INFUSION, LLC TRANSFERRED OWNERSHIP AND ASSETS TO WALKMED, LLC. ADDITIONALLY, ON (B)(6) 2017, CANNON QUALITY GROUP WAS CONTRACTED TO ASSIST WITH THE QUALITY MANAGEMENT SYSTEM TRANSITION, INCLUDING MANAGEMENT OF COMPLAINTS. AT THE TIME THIS COMPLAINT WAS RECEIVED ON (B)(6) 2017, WALKMED HAD APPLIED FOR A NEW EMDR ACCOUNT AND WAS WAITING FOR ACCOUNT APPROVAL. DUE TO THE TRANSITIONS AND EMDR ACCOUNT SET UP WAITING PERIOD, WALKMED WAS UNABLE TO REPORT THIS EVENT WITHIN 30 DAYS. UPON RECEIVING EMDR ACCOUNT APPROVAL, REPORTING THIS EVENT WAS AN IMMEDIATE PRIORITY AND WALKMED STRIVED TO SUBMIT THIS REPORT IN A TIMELY MANNER. FDA WAS CONTACTED, REGARDING THE LATE MDRS AND SECTION HAS BEEN COMPLETED PER THEIR RECOMMENDATION. A SEPARATE MDR REPORT WAS GENERATED FOR THE THREE (3) PATIENTS WHO WERE USING 5FU MEDICATION AT THE TIME OF THE EVENTS ON (B)(6) 2017 AND (B)6) 2017. AN MDR REPORT WAS NOT GENERATED FOR THE PHARMACIST WHO DISCOVERED THE LEAK DURING SET UP, AS IT WAS DETERMINED THAT THERE WAS NO POTENTIAL EXPOSURE TO HAZARDOUS MEDICATION RELATED TO THAT PARTICULAR EVENT AND NO INDICATION THAT THERE WOULD BE POTENTIAL FOR SERIOUS INJURY IF THAT PARTICULAR EVENT WERE TO RECUR. THE ACTUAL DEVICE WAS RETURNED TO REXMED, NOT WALKMED, ON 03/03/2017. REXMED OPENED A COMPLAINT, #17-003 AND INVESTIGATED THE DEVICE. REXMED CONFIRMED A LEAK IN THE DEVICE LUER LOCK BUT COULD NOT DETERMINE A ROOT CAUSE. NEVERTHELESS AS A CONTAINMENT ACTION, REXMED IS CHECKING THAT THE LUER LOCK HAS NO FISSURE DAMAGE BEFORE THE RESERVOIR BAG HAS BEEN SENT.

D

Patient 1

THERE WERE 4 INDIVIDUAL EVENTS INVOLVING A LEAK WITH 4 DIFFERENT WALKMED INFUSION'S IPR BAGS FROM LOT 20816500 (REF 204820, LOT 20816500). EACH EVENT INVOLVED ONE PERSON, FOR A TOTAL FOUR (4) PEOPLE. A TOTAL OF THREE PATIENTS WERE EXPOSED TO MEDICATION DURING THEIR TREATMENT (ON (B)(6) 2017 TWO PATIENTS WERE AFFECTED AND ON (B)(6) 2017 ONE PATIENT WAS AFFECTED). YES 5FU WAS BEING ADMINISTERED. THE LEAK WAS COMING FROM THE SITE BETWEEN THE LUER LOCK AND THE TUBING CONNECTED TO THE IPR BAG. ADDITIONALLY, ON (B)(6) 2017 A PHARMACIST FOUND THE LEAK BEFORE GIVEN TO PATIENT, NO 5FU WITH THIS ONE SO THERE WAS NO POSSIBLE CHEMICAL EXPOSURE. NO INJURIES TO PATIENT OR STAFF.