BACT/ALERT 3D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-08 for BACT/ALERT 3D manufactured by Biomerieux.

Event Text Entries

[1418839] Facility utilizes the bact/alert bacterial impurities limit test for the bacterial screening of all apheresis platelet products. This screening process continues throughout the -5 day- expiration timeframe of each product, and these units are released to hospital consignees during the monitoring period. If there is a screening positive on a product that has been released to a hospital, a system alarm notifies a staff who immediately contact the consignee and advise them not to transfuse the unit. On two occasions, within a four month period, the controller has failed on one device used by the facility. As a result, the screening bottles are neither rotated within the device nor monitored for positive results. There is no alarm to signal this failure mode and thus, the failure may exceed the mfr's timeframe specs for bottle rotation/monitoring. As a consequence, facility loses the ability to immediately identify potential positive screening results and monitor the test status of units associated with the failed device. Although the mfr has stated that this type of failure is a "rare" event, we have advised him that it is unacceptable and a system improvement must be implemented.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5014287
• MDR Report Key: 1577564
• Date Received: 2010-01-08
• Date of Report: 2010-01-08
• Date of Event: 2010-01-07
• Date Added to Maude: 2010-01-19
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BACT/ALERT 3D
• Generic Name: SDP BACTERIAL IMPURITIES LIMIT TEST
• Product Code: JTA
• Date Received: 2010-01-08
• Model Number: BACT/ALERT 3D
• Lot Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMERIEUX
• Manufacturer Address: 100 RODOLPHE ST. DURHAM NC 27712 US 27712

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2010-01-08