FDA Adverse Event Malfunction Summary report: N

MAXPLUS POSITIVE PRESSURE CONNECTOR

MDR report key: 8689583 · Received June 11, 2019

Report

Report Number: 9616066-2019-01591
Event Type: Malfunction
Date Received: June 11, 2019
Report Date: May 14, 2019
Manufacturer: CAREFUSION
Product Code: FPA
UDI-DI: 10885403223228
PMA / PMN Number: K072542
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. PATIENT DEMOGRAPHICS REQUESTED HOWEVER NOT PROVIDED.

Additional Manufacturer Narrative · 1

THE CUSTOMER¿S REPORT OF A MAXPLUS FAILURE IDENTIFIED AS A VALVE STICKDOWN WAS CONFIRMED. VISUAL INSPECTION OF THE VALVE NOTED DRIED BLOOD. THERE WERE NO OTHER ANOMALIES OBSERVED. FUNCTIONAL AND PRESSURE TESTING RESULTED IN NO LEAKING. WHEN DEACTIVATING THE VALVE, IT WAS OBSERVED THAT THE VALVE'S RETURN BEHAVIOR STAYED STUCK DOWN. THE VALVE RETURN WAS NOTED AS A GRADE 4 CATEGORY AND THE VALVE IS CONSIDERED AN UNACCEPTABLE PART. THE ROOT CAUSE OF VALVE SLOW RETURN/STICKDOWN WAS IDENTIFIED AS A VALVE MOLDING ISSUE (MISMATCH OUT OF SPECIFICATION).

Description of Event or Problem · 1

THE CUSTOMER REPORTED A MAXPLUS FAILURE AT (B)(6). ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.

Description of Event or Problem · 1

THE CUSTOMER REPORTED A MAXPLUS FAILURE AT LCI SOUTHPARK . ALTHOUGH REQUESTED, NO FURTHER DETAILS WERE PROVIDED BY THE CUSTOMER FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
481891	MAXPLUS POSITIVE PRESSURE CONNECTOR	SET, ADMINISTRATION, INTRAVASCULAR	FPA	CAREFUSION	MP1000-C	19016677	10885403223228

Patients

Seq	Age	Sex	Outcome	Treatment
1