FDA Adverse Event Malfunction Summary report: N

SOLUSET 100X60W/CAI

MDR report key: 3367457 · Received August 6, 2013

Report

Report Number: 9615050-2013-02289
Event Type: Malfunction
Date Received: August 6, 2013
Date of Event: July 9, 2013
Report Date: July 9, 2013
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FPA
PMA / PMN Number: UNK
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. TESTING AND INVESTIGATION IS COMPLETE. THE DEVICE WAS NOT RECEIVED. DURING THE INVESTIGATION, NO POSSIBLE CAUSES FOR THE CUSTOMER REPORTED LEAK WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT. THE COMMODITY ON THE INTERNATIONAL LIST NUMBER THAT MALFUNCTIONED IS COMPARABLE TO THE COMMODITY ON THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF (B)(4) AND HAS A 510K OF K101677. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED A LEAK. THE TUBING SET WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION. IT WAS REPORTED THAT DURING PRIMING OF THE TUBING SET PRIOR TO PT USE, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED AT AN UNSPECIFIED LOCATION OF THE TUBING SET. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS INITIATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
368568	SOLUSET 100X60W/CAI	UNK	FPA	HOSPIRA COSTA RICA LTD.	NA	152435G

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA