MAUDE Adverse Event Report: OAKDALE LEVEL 1; WARMER, THERMAL, INFUSION FLUID

Model Number L-70

Device Problem Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2021

Event Type  malfunction  

Event Description

During the pre-use check, the customer attempted to connect the product to an infusion line, but the connector did not turn.He made another attempt using a pair of forceps, but could not make it.No patient injury.

Manufacturer Narrative

Other text: device evaluation one sample was returned for evaluation.The device was inspected; this showed no damage.The reflux connector did not turn.No leakage occurred during functional testing.The issue with the connector occurred during manufacturing.

Manufacturer Narrative

Other, other text: device evaluation- one sample was returned for evaluation.The device was inspected; this showed no damage.The reflux connector did not turn.No leakage occurred during functional testing.The issue with the connector occurred during manufacturing., corrected data: g1 corrected to show updated manufacturing site.

• Brand Name: LEVEL 1
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12467058
• MDR Text Key: 271248719
• Report Number: 3012307300-2021-09341
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 30695085407007
• UDI-Public: 30695085407007
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L-70
• Device Catalogue Number: L-70
• Device Lot Number: 4085003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1