FDA Adverse Event Malfunction Summary report: N

COLLEAGUE

MDR report key: 2242163 · Received September 9, 2011

Report

Report Number: 6000001-2011-23793
Event Type: Malfunction
Date Received: September 9, 2011
Date of Event: August 18, 2011
Report Date: August 18, 2011
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
PMA / PMN Number: K041191
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE CONDITION WAS CONFIRMED BY SERVICE. THIS COMPLAINT IS AN ANCILLARY SERVICE EVENT OPENED DURING THE INVESTIGATION OF (B)(4). THE CAUSE WAS IDENTIFIED TO BE THE DAMAGED POWER CORD. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED DUE TO ESTIMATE REFUSAL BY CUSTOMER. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SENT.

Description of Event or Problem · 1

DURING PRODUCT EVALUATION BY BAXTER PERSONNEL, A COLLEAGUE INFUSION PUMP WAS FOUND TO HAVE FAILED A POWER CORD CONDITION TEST. 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. THIS DEVICE IS AN UNREMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.04.00. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1