FDA Adverse Event Malfunction Summary report: N

WALKMED PUMP TUBING SET FOR WALKMED INFUSION PUMP 152CM

MDR report key: 6961015 · Received October 19, 2017

Report

Report Number
MW5072828
Event Type
Malfunction
Date Received
October 19, 2017
Date of Event
September 13, 2017
Report Date
September 28, 2017
Manufacturer
WALKMED INFUSION, LLC
Product Code
FRN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

A PATIENT REPORTED A LEAK WITH THEIR 5-FU PUMP THAT WAS PLACED ON (B)(6) 2017. SEVERAL OTHER PATIENTS PRESENTED WITH SIMILAR COMPLAINTS. THOSE PATIENTS WERE ASKED TO RETURN TO THE FACILITY, (B)(6), FOR A REPLACEMENT PUMP. AT THE FACILITY, THERE WERE 5-FU LEAKAGES THAT OCCURRED ON (B)(6) 2017 BEFORE THEY WERE GIVEN TO THE PATIENTS. AS A RESULT, NEW SETS WERE PREPARED. ON (B)(6) 2017, A PATIENT WENT TO THE EMERGENCY DEPARTMENT DUE TO A 5-FU PUMP LEAKAGE. ON (B)(6) 2017, ANOTHER PATIENT CALLED THE FACILITY WITH A COMPLAINT OF A LEAKAGE IN THEIR PUMP. THE REMAINING PATIENTS WERE IMMEDIATELY CALLED IN FOR THE REMOVAL OF THEIR WALKMED PUMPS. THERE WAS NO PATIENT HARM, AND NO PATIENT EXPOSURE. A DIFFERENT BRAND WAS USED TO REPLACE ALL OF THE PUMPS THAT WERE BEING USED BY THESE PATIENTS. THE PUMP SUPPLIER ISSUED A VOLUNTARY RECALL AND NOTIFIED ALL OF THEIR FACILITIES BEING SERVICED BY THEM OF RECENT ISSUES THAT HAD TAKEN PLACE. (B)(6) IS CURRENTLY SEEKING TO WORK WITH A DIFFERENT SUPPLIER. THE WALKMED PUMP TUBING SET FOR WALKMED INFUSION PUMP 152CM LOT NUMBERS THAT APPEARED TO BE DEFECTIVE WERE LOT NUMBERS: 20217508, 20317530, 20715517. DIAGNOSIS OR REASON FOR USE: CANCER TREATMENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
743428 WALKMED PUMP TUBING SET FOR WALKMED INFUSION PUMP 152CM INFUSYSTEM FRN WALKMED INFUSION, LLC 20217508
743429 WALKMED PUMP TUBING SET FOR WALKMED INFUSION PUMP 152CM INFUSYSTEM FRN WALKMED INFUSION, LLC 20317530
743430 WALKMED PUMP TUBING SET FOR WALKMED INFUSION PUMP 152CM INFUSYSTEM FRN WALKMED INFUSION, LLC 20715517

Patients

Seq Age Sex Outcome Treatment
1 51 YR