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

Model Number HL-90

Device Problems Device Alarm System (1012); Electrical /Electronic Property Problem (1198); Grounding Malfunction (1271)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: date of event is unknown, no 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 device "trips electrical safety monitor.Analyzer error message.Ground fault occurred." patient involvement is unknown.

Manufacturer Narrative

Other, other text: g1,2 email is: regulatory.Responses@icumed.Com.One device was received.Per visual inspection, outdated printed circuit board (pcb) and power switch, line cord faded and worn, quick connect corroded, multiple scratches on enclosure and front cover, plate clip contaminated, missing reflux plug.Per functional testing, the device failed electrical testing on the analyzer.The complaint was confirmed.The root cause was a faulty heater.It was unknown what caused the condition.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Replaced heater, outdated pcb, power switch cable, power switch retainer, membrane switch, quick connect, interlock block, plate clip, microswitch, line cord, front cover, reflux plug and labels.Performed preventative maintenance (pm), changed o-rings, reservoir gasket and calibrated.The device passed all functional and delivery tests.

• 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: 18066933
• MDR Text Key: 327307016
• Report Number: 3012307300-2023-10217
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085820909
• UDI-Public: 50695085820909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911383
• 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: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1