SENSATION 7FR, 40CC IAB

MDR report key: 3946218 · Received July 2, 2014

Report

Report Number: 2248146-2014-00196
Event Type: Death
Date Received: July 2, 2014
Date of Event: July 8, 2013
Report Date: July 8, 2013
Manufacturer: DATASCOPE CORP.
Product Code: DSP
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS NOT RETURNED FOR EVALUATION. (B)(4).

Description of Event or Problem · 1

RECEIVED A CALL STARTING AT 5:20 PM CST (B)(6) 2013. PATIENT ON A CS300 WITH A SENSATION 40CC SN NUMBER (B)(4). PROBLEM WAS: OPTICAL SENSOR FAILURE. TRIED DISCONNECT, RECONNECT AND ALSO SECOND PUMP TO NO AVAIL. CENTRAL LUMEN PATIENT WITH FLUSH BAG ATTACHED. SWITCHED TO FLUID SYSTEM AND DISCONNECTED FIBER OPTIC AND ALL WAS RUNNING WELL. INSTRUCTED TO FLUSH Q1 BECAUSE OF TIGHT LUMEN. INSTRUCTED TO ASK ICU TO SAVE CATHETER FOR EVALUATION POST REMOVAL. PRODUCT CAN NOT BE FOUND. THE BALLOON WAS STILL WORKING IN PATIENT EVEN THOUGH THERE WAS AN ISSUE WITH THE FIBER OPTIC SIGNAL. DIFFICULTIES ENCOUNTERED DURING PUMPING. NO BLOOD SEEN IN THE CATHETER TUBING. NO PATIENT INJURY OR DEATH RESULTING FROM THE EVENT. THERE WERE 3 DIFFERENT DEPARTMENTS INVOLVED WITH THE SAME IAB. THIS WAS INITIATED IN CATH LAB, THEN THE PATIENT WENT TO UNIT, THEN OPERATING ROOM, THEN UNIT AGAIN. THE ACCOUNT MANAGER SPOKE WITH ALL DEPARTMENTS ASKING THEM TO PLEASE KEEP IAB. IT WAS DISCARDED. IAB WORKING JUST UTILIZING CENTRAL LUMEN INSTEAD OF FIBER-OPTIC. CURRENT PATIENT STATUS: EXPIRED (IAB WORKED FINE AND WAS NOT THE CAUSE).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
385300	SENSATION 7FR, 40CC IAB	INTRA-AORTIC BALLOON	DSP	DATASCOPE CORP.	0684-00-0434	2940

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death