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

Model Number H-1200

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other text: b3: date of event and d4:udi section is unknown.No product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the ramp time on the device was taking longer and exceeding the temp.The two clam was not releasing.Patient involvement is unknown.

Manufacturer Narrative

Other, other text: for all enquiries or follow-up questions related to the record, do (b)(6)additional information: a1, b3, b5 and h6 - health effects codes.H3 and h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found the device was leaking from drain valve.Device had an old style float switch intact.Functional testing found the plunger gets stuck during the pin gauge test on the air detector.Unable to duplicate ramp time as the temp performed during cold start: in 60 seconds temp reached 30 degrees celsius.And by 3 mins temp reached 41.7 degrees celsius.Display temp and tempcheck temp were stable for 45 mins, but both out of spec at 41.9 degrees celsius; exceeding the temp.The complaint was confirmed.Root cause was attributed to assembly error.The optical cable is in the way of the solenoid to go up and down.Needs calibration to the unit.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.Re-assembled to re-tight and re-installed the optical cable.Performed calibration to the unit.Rreplaced the o-rings and the fan guard for pm.Replaced the drain valve and float switch.

Event Description

Additional information received: date of event updated from unknown to (b)(6) 2023.The product fault occurred during preventive maintenance procedures while performing temperature ramp test per the published manufacturer instructions.No patient injury.Temperature ramp performance date for the cold start test performance was attached to the complaint and investigation.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 17367599
• MDR Text Key: 319649936
• Report Number: 3012307300-2023-07332
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK940056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H-1200
• Device Catalogue Number: 8002950
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1