PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM

Report

Report Number: 9615050-2013-01760
Event Type: Malfunction
Date Received: June 27, 2013
Date of Event: January 1, 2013
Report Date: May 29, 2013
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SP
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER INDICATED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THE LOT NUMBER OF THE DEVICES THAT WERE IN USE IS UNK. THE CUSTOMER CONTACT IDENTIFIED A POSSIBLE LOT NUMBER (PLOTS). THE POSSIBLE LOT NUMBER IS 281575H. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE 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 K033576. 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 THE PINCH CLAMPS DID NOT CLAMP. ON UNSPECIFIED DATES, THE TUBING SETS WERE BEING USED TO DELIVER UNSPECIFIED MEDICATIONS, AT UNSPECIFIED RATES. AFTER UNSPECIFIED LENGTHS OF TIME, THE CUSTOMER CONTACT REPORTED THAT THE PINCH CLAMPS ON THE TUBING SETS DID NOT CLOSE. NO SPECIFIC DETAILS WERE PROVIDED. ALTHOUGH THERE WAS POTENTIAL FOR A LEAK, NO LEAKAGE WAS REPORTED. THERE WERE NO REPORTS OF ADVERSE PT EFFECTS AND NO REPORTED DELAYS OF THERAPIES CRITICAL TO THESE PTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED INCLUDING IF THE TUBING SETS WERE REPLACED AND THE THERAPIES WERE RESUMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
293363	PLUM 4-PORT 15 FLTR 2CLV PE LINE 216CM	UNK	FRN	HOSPIRA COSTA RICA LTD.	NA	PLOTS5H5H

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK