FDA Adverse Event Malfunction Summary report: N

PLUM A+ DRIVER ED 2

MDR report key: 2971428 · Received February 4, 2013

Report

Report Number: 9615050-2013-00181
Event Type: Malfunction
Date Received: February 4, 2013
Date of Event: January 15, 2013
Report Date: January 15, 2013
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
PMA / PMN Number: K042081
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TESTING AND INVESTIGATION FOUND THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. THIS WAS DUE TO A BROKEN DISTAL PRESSURE SENSOR PIN TIP. DISTAL PRESSURE SENSING ON THE DEVICE IS ACCOMPLISHED BY SENSING THE MOVEMENT IN A STRAIN GAUGE THAT MAKES CONTACT WITH THE CASSETTE TUBING. THE DISTAL PRESSURE SENSOR PIN TIP IS MOUNTED ON THE DISTAL PRESSURE SENSOR STEM AND MAKES CONTACT WITH THE CASSETTE. THE DISTAL PRESSURE SENSOR COULD NOT PROPERLY SENSE THE DISTAL OCCLUSION BECAUSE THE DISTAL PRESSURE SENSOR PIN TIP WAS BROKEN OFF. THE PROBABLE CAUSE OF THE BROKEN DISTAL PRESSURE SENSOR PIN TIP WAS MISUSE IN THE CUSTOMER ENVIRONMENT. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED THAT DURING PREVENTIVE MAINTENANCE TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN A DISTAL OCCLUSION WAS PRESENT. 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 ADD'L INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
47386	PLUM A+ DRIVER ED 2	80FRN	FRN	HOSPIRA COSTA RICA LTD.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA			PLUM A+ SOFTWARE MODULE, LIST #20791,\| SN (B)(4)