MAUDE Adverse Event Report: OAKDALE LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number 8002950

Device Problem Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device was not pumping water.No patient injury was reported.

Manufacturer Narrative

Other, other text: d10, h3, and h6 - health impact and evaluation codes: updated device evaluation: one device was returned for investigation.Visual inspection noted: physical damage on the enclosure, nicks and scrapes on front of enclosure, damage to the water tank label, damage to the bottom right rear of enclosure, corroded drain valve, and the membrane switch was burnt.Functional testing confirmed the complaint.A cracked return tube was leaking onto the printed circuit board (pcb).Root cause was attributed to design.The product was beyond a year from manufacture date and there was no indication of a manufacturing defect during the investigation, so a device history report (dhr) review was not required.Service history review identified this device has not been in for service previously.Removed and replaced: pcb (due to fluid ingression), membrane switch and pcb insulator (due to membrane switch being burnt), drain valve (due to corrosion), float switch tape, air regulator (due to it leaking), label set, orings and fan guard (for preventative maintenance-pm).Device passed all functional testing after completed repairs., corrected data: d3 and g2.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15046614
• MDR Text Key: 304038660
• Report Number: 3012307300-2022-13544
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8002950
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1