FDA Adverse Event Malfunction Summary report: N

DIALYSIS UNKNOWN

MDR report key: 8537901 · Received April 22, 2019

Report

Report Number: 3009211636-2019-00100
Event Type: Malfunction
Date Received: April 22, 2019
Report Date: April 22, 2019
Manufacturer: COVIDIEN MFG SOLUTIONS S.A.
Product Code: FJS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TITLE COLLECTION OF PERIPHERAL BLOOD STEM CELLS FROM A (B)(6)-OLD GIRL WITH THE USE OF COMBINED HEPARIN AND CITRATE ANTICOA GULATION SOURCE JOURNAL OF CLINICAL APHERESIS, VOLUME 28, 2013 (309¿310) DATE OF PUBLICATION: 24 JULY 2013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

Description of Event or Problem · 1

ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED 2013, ON A PREVIOUSLY HEALTHY GIRL ((B)(6)) WHO WAS DIAGNOSED WITH STAGE IV NEUROBLASTOMA, A DOUBLE LUMEN CATHETER WAS PLACED IN THE RIGHT FEMORAL VEIN. THE PLAN WAS TO PERFORM APHERESIS AND PROCESS A TOTAL OF FOUR BVS (BLOOD VOLUMES), AMOUNTING TO 2,100 ML OF BLOOD, BUT, UNFORTUNATELY, THE LINE STOPPED WORKING SHORTLY AFTER THE START OF THE PROCEDURE DESPITE SERIAL FLUSHING WITH NS 0.9%. ONE MG OF ALTEPLASE INFUSION IN EACH LUMEN WAS PARTIALLY SUCCESSFUL IN RESTORING THE BLOOD FLOW, AND IT WAS POSSIBLE TO PROCESS 1.3 BVS. THE FOLLOWING DAY THE LINE WAS CHANGED OVER A GUIDE WIRE. THERE WAS NO REPORTER PATIENT OUTCOME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
328883	DIALYSIS UNKNOWN	CATHETER, PERITONEAL, LONG-TERM INDWELLING	FJS	COVIDIEN MFG SOLUTIONS S.A.	DIALYSIS UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	1 YR