FDA Adverse Event Malfunction Summary report: N

PRIMARY SYMBIQ CLAVE Y-SITE, 105 IN

MDR report key: 1840041 · Received September 16, 2010

Report

Report Number: 9615050-2010-00171
Event Type: Malfunction
Date Received: September 16, 2010
Date of Event: August 1, 2010
Report Date: August 17, 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: KY, 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 THE PT RECEIVED LESS MEDICATION THAN INTENDED. THE TUBING SET WAS CONNECTED TO A FILTER EXTENSION SET AND WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF PITOCIN, VIA A SYMBIQ PUMP, TO THE PT WHO WAS IN LABOR. AFTER THE PT DELIVERED THE INFANT, IT WAS REPORTED THAT THE PT BEGAN TO HEMORRHAGE. IT WAS REPORTED THE TUBING SET WAS REMOVED FROM THE PUMP TO DELIVER THE PITOCIN AT AN UNSPECIFIED FASTER RATE; HOWEVER, THE ANESTHESIOLOGIST REPORTED THE FLOW RATE WAS NOT FAST ENOUGH. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. ALTHOUGH REQUESTED, THE CUSTOMER CONTACT COULD NOT PROVIDE ANY ADD'L EVENT INFO, INCLUDING WHAT WAS DONE TO INCREASE THE RATE OF DELIVERY OF THE MEDICATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRIMARY SYMBIQ CLAVE Y-SITE, 105 IN	80FRN	FRN	HOSPIRA COSTA RICA LTD.	NA	UNK5H

Patients

Seq	Age	Sex	Outcome	Treatment
1				MACROBORE EXTENSION SET\| LIST #20668, LOT #UNK