FDA Adverse Event Malfunction Summary report: N

COLLEAGUE

MDR report key: 2231458 · Received September 1, 2011

Report

Report Number: 6000001-2011-22073
Event Type: Malfunction
Date Received: September 1, 2011
Date of Event: August 15, 2011
Report Date: August 16, 2011
Manufacturer: BAXTER HEALTHCARE - SINGAPORE
Product Code: FRN
PMA / PMN Number: K063696
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE CONDITION OF A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY WAS CONFIRMED AND REPRODUCED DURING SERVICE BY A BAXTER SERVICE TECHNICIAN. THE ROOT CAUSE WAS DETERMINED TO BE DEPLETED MAIN BATTERIES. THIS CONDITION WAS RESOLVED ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN REPLACING THE MAIN BATTERIES AND BATTERY HARNESS. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.90.

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE IS CURRENTLY IN THE PROCESS OF BEING EVALUATED ONSITE AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

Description of Event or Problem · 1

THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS EVENT MAY HAVE INTERRUPTED DELIVERY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

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