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

Model Number HL-90

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that it appears the device has a small amount of water leaking from it, as well as the pole clamp is not properly rotating and just spins on the device.Patient involvement is unknown.

Manufacturer Narrative

Other text: b3: date of event is unknown.No information received 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.

Manufacturer Narrative

Device evaluation: one device was returned for investigation.Visual inspection noted the device had cracks on the water tank enclosure, pole clamp screw was lose, and the reflux plug was broken.Functional testing began with filling to check if device is leaking - leak was confirmed.Pole clamp was tested - screw is loose."pwa" was also visually checked and the plastic display support was missing.After replacing the damaged/broken parts device was tested and temperature was set.Complaint was confirmed.What caused the damage could not be established.Service history review identified the device had been returned within 2 weeks for prior service where routine maintenance service was performed in (b)(6) 2023.The tank gasket and interlock block o-rings were replaced per debrief records.Therefore, the tank cover showed no damage during the prior repair and no damage to the pole clamp and reflux plug was noted, implying the device likely sustained a physical damage after the last repair.Water tank enclosure, pole clamp, "pwa" and on/off switch were replaced.Device passed functional testing after the completed repairs.

• Brand Name: LEVEL 1 HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17607598
• MDR Text Key: 321829672
• Report Number: 3012307300-2023-08362
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K911383
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HL-90
• Device Catalogue Number: HL-90-UK-230
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1