FDA Adverse Event Malfunction Summary report: N

LTXF SYM CONVTP 3CLV

MDR report key: 1930376 · Received October 29, 2010

Report

Report Number: 9615050-2010-00213
Event Type: Malfunction
Date Received: October 29, 2010
Date of Event: July 31, 2010
Report Date: October 4, 2010
Manufacturer: HOSPIRA COSTA RICA LTD
Product Code: FRN
PMA / PMN Number: K041550
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

USER FACILITY VOLUNTARY MEDWATCH REPORT WAS RECEIVED ON 10/04/2010. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. (B)(4).

Description of Event or Problem · 1

USER FACILITY VOLUNTARY MEDWATCH RECEIVED FROM CDRH THAT STATED: "THE LIFESHIELD SYMBIQ PUMP 150ML BURETTE SET HOSPIRA LIST NUMBER 16014-01 HAD A DEFECT. THE BAG SPIKE SEPARATED FROM THE TUBING AND THE ENTIRE CONTENTS OF A NEONATAL TPN WAS SPILLED." UPON FURTHER QUERY, THE FOLLOWING INFORMATION WAS PROVIDED THAT INDICATED A TUBING SEPARATION. THE TUBING SET WAS TO BE USED TO DELIVER TPN TO A NEONATE. IT WAS REPORTED THAT DURING PRIMING IN THE PHARMACY PRIOR TO PATIENT USE, THE TUBING SEPARATED FROM THE PIERCING PIN AND THE TPN SPILLED. THE PHARMACIST THEN PREPARED A "NON-TPN" THERAPY OF DEXTROSE 10% WITH TROPHAMINE. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE "NON-TPN" WAS DELIVERED TO THE PATIENT. THE CUSTOMER CONTACT REPORTED THAT UNSPECIFIED LABWORK WAS DRAWN THAT INDICATED THERE WAS NO CHANGE IN THE PATIENT'S GLUCOSE OR ELECTROLYTES VALUES. ALTHOUGH THERE WAS THE POTENTIAL FOR SERIOUS INJURY, THERE WAS NO CHANGE IN THE PATIENT'S CONDITION. NO MEDICAL INTERVENTIONS WERE REQUIRED THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LTXF SYM CONVTP 3CLV	80FRN	FRN	HOSPIRA COSTA RICA LTD	NA	690365H

Patients

Seq	Age	Sex	Outcome	Treatment
1	5 DA