SMALL ADULT CUSTOM PACK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-01 for SMALL ADULT CUSTOM PACK * manufactured by Medtronic Inc.

Event Text Entries

[6542448] Discovered oxygenator leak when setting up small adult custom tubing pack (medtronic lot# 209471154) with affinity 540t oxygenator. The case was setup and primed before the patient entered the cath lab. The leak was discovered per standard of practice during setup and inspection. The oxygenator was changed out, reprimed and showed no leaks during inspection. Case was completed without using bypass; this event did not result in delays or complications to the plan of care. This event is similar to two other events that occurred approximately 1 week ago.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4894282
• MDR Report Key: 4894282
• Date Received: 2015-07-01
• Date of Report: 2015-07-01
• Date of Event: 2015-06-09
• Report Date: 2015-07-01
• Date Added to Maude: 2015-07-07
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: SMALL ADULT CUSTOM PACK
• Generic Name: CUSTOM ANESTHESIA KIT
• Product Code: OFQ
• Date Received: 2015-07-01
• Model Number: *
• Catalog Number: *
• Lot Number: 209471154
• ID Number: *
• Device Availability: N
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC INC
• Manufacturer Address: 710 MEDTRONIC PKWY. MINNEAPOLIS MN 55432 US 55432

Device Sequence Number: 2

• Brand Name: AFFINITY 540T OXYGENATOR
• Generic Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Product Code: OFQ
• Date Received: 2015-07-01
• Model Number: 540T
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDTRONIC INC
• Manufacturer Address: 710 MEDTRONIC PKWY. MINNEAPOLIS MN 55432 US 55432

Device Sequence Number: 3

• Brand Name: SMALL ADULT CUSTOM PACK
• Generic Name: CUSTOM ANESTHESIA KIT
• Product Code: OFQ
• Date Received: 2015-07-01
• Model Number: *
• Catalog Number: *
• Lot Number: 209192552
• ID Number: *
• Device Availability: R
• Device Age: 1 DA
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MEDTRONIC INC
• Manufacturer Address: 710 MEDTRONIC PKWY. MINNEAPOLIS MN 55432 US 55432

Device Sequence Number: 4

• Brand Name: AFFINITY 540T OXYGENATOR
• Generic Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Product Code: OFQ
• Date Received: 2015-07-01
• Model Number: 540T
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: MEDTRONIC INC
• Manufacturer Address: 710 MEDTRONIC PKWY. MINNEAPOLIS MN 55432 US 55432

Device Sequence Number: 5

• Brand Name: SMALL ADULT CUSTOM PACK
• Generic Name: CUSTOM ANESTHESIA KIT
• Product Code: OFQ
• Date Received: 2015-07-01
• Model Number: *
• Catalog Number: *
• Lot Number: 209471154
• ID Number: *
• Device Availability: R
• Device Age: 1 DA
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: MEDTRONIC INC
• Manufacturer Address: 710 MEDTRONIC PKWY. MINNEAPOLIS MN 55432 US 55432

Device Sequence Number: 6

• Brand Name: AFFINITY 540T OXYGENATOR
• Generic Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Product Code: OFQ
• Date Received: 2015-07-01
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: *
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: MEDTRONIC INC
• Manufacturer Address: 710 MEDTRONIC PKWY. MINNEAPOLIS MN 55432 US 55432

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-07-01