FDA Adverse Event Malfunction Summary report: N

FLOGARD

MDR report key: 2924004 · Received January 22, 2013

Report

Report Number: 1416980-2013-01507
Event Type: Malfunction
Date Received: January 22, 2013
Date of Event: November 7, 2012
Report Date: November 7, 2012
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
PMA / PMN Number: K915523
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PR
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS SERVICED BY A SERVICE TECHNICIAN. (B)(4). THE ROOT CAUSE OF THE DAMAGED SAFETY SLIDE CLAMP ASSEMBLY IS UNKNOWN. NO REPAIRS HAVE BEEN PERFORMED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT. CONCLUSION: THE PROBLEM WAS CONFIRMED. HOWEVER, THE PROBLEM CANNOT CONCLUSIVELY BE ASSIGNED TO A HUMAN FACTORS ISSUE. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION IS IN PROGRESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem · 1

DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, A FLOGARD VOLUMETRIC INFUSION PUMP WAS FOUND TO HAVE A DAMAGED SAFETY/SLIDE CLAMP ASSEMBLY. THIS WAS NOT REPORTED BY THE CUSTOMER. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
29383	FLOGARD	PUMP, INFUSION	FRN	BAXTER HEALTHCARE - SINGAPORE

Patients

Seq	Age	Sex	Outcome	Treatment
1