FDA Adverse Event Malfunction Summary report: N

SPECTRUM INFUSION PUMP

MDR report key: 4850562 · Received June 15, 2015

Report

Report Number: 1314492-2015-06807
Event Type: Malfunction
Date Received: June 15, 2015
Date of Event: May 1, 2015
Report Date: May 21, 2015
Manufacturer: BAXTER HEALTHCARE CORP
Product Code: FRN
PMA / PMN Number: K042121
Removal / Correction Number: Z-1484-2014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE IN QUESTION. THE EVAL WAS ABLE TO CONFIRM THE SYSTEM ERROR 322 ALARM THROUGH REVIEW OF THE DEVICE EVENT HISTORY LOG. THE ALARM COULD NOT BE REPRODUCED AND A CAUSE COULD NOT BE IDENTIFIED. THE PUMP WAS TESTED WITH PASSING RESULTS. BAXTER HAS INITIATED AN APPROVED REMEDIAL ACTION; HOWEVER THIS DEVICE HAS A VERSION OF SOFTWARE THAT DOES NOT HAVE AN APPROVED SOFTWARE UPDATE. THE DEVICE WAS FOUND TO BE OPERATING MECHANICALLY AS DESIGNED AND NO ACTION WILL BE TAKEN AT THIS TIME. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED THAT A SPECTRUM PUMP DISPLAYED SYSTEM ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
389437	SPECTRUM INFUSION PUMP	INFUSION PUMP	FRN	BAXTER HEALTHCARE CORP	35700

Patients

Seq	Age	Sex	Outcome	Treatment
1