FDA Adverse Event Malfunction Summary report: N

RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)

MDR report key: 2152678 · Received June 24, 2011

Report

Report Number: 9613251-2011-00130
Event Type: Malfunction
Date Received: June 24, 2011
Date of Event: May 1, 2011
Report Date: May 26, 2011
Manufacturer: HOSPIRA LTD.
Product Code: GCX
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER INDICATED THE DEVICES WERE DISCARDED. THE DEVICES WERE NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICES COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80GCX AND HAS A 510K OF K831939. THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LOSS OF SUCTION. THE DEVICES WERE TO BE USED DURING UNSPECIFIED PROCEDURES. IT WAS REPORTED THAT DURING SET UP AFTER THE DEVICES WERE CONNECTED TO AN UNSPECIFIED VACUUM SOURCE, A LOSS OF SUCTION WAS NOTED. THE DEVICES WERE REPLACED AND THE PROCEDURES WERE RESUMED. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RECEPTAL 1 LITER/CE WITH VALVE (50/CAS)	UNK	GCX	HOSPIRA LTD.	NA	73035KZ

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA