FDA Adverse Event Malfunction Summary report: N

GEMSTAR DOCK STA

MDR report key: 1915207 · Received November 2, 2010

Report

Report Number: 2921482-2010-00844
Event Type: Malfunction
Date Received: November 2, 2010
Date of Event: September 27, 2010
Report Date: October 4, 2010
Manufacturer: HOSPIRA, INC.
Product Code: FRN
PMA / PMN Number: K060806
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED DURING PREVENTATIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT DELIVER. IT WAS REPORTED THAT AN UNSPECIFIED GEMSTAR PUMP AND BOLUS CORD WERE CONNECTED TO A GEMSTAR DOCKING STATION. DURING TESTING, IT WAS REPORTED THAT AFTER THE BUTTON ON THE BOLUS CORD WAS PRESSED, THE DEVICE DID NOT SOUND AN AUDIBLE TONE THAT INDICATED A DOSE WAS DELIVERED. THE BIOMEDICAL ENGINEER REMOVED THE BOLUS CORD FROM THE BACK OF THE DOCKING STATION AND NOTED THAT AN UNSPECIFIED NUMBER OF CONTACT PINS WERE MISSING FROM THE BOLUS CORD CONNECTION PORT OF THE DOCKING STATION. 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 ADDITIONAL INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GEMSTAR DOCK STA	80FRN	FRN	HOSPIRA, INC.	NA	84824G1

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA			SN UNK\| LIST #UNK\| GEMSTAR BOLUS CORD\| LIST #13027\| LOT #UNK\| GEMSTAR PUMP,