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

Model Number	H-1129
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power pole was not rising with weight on it.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).The original device history record (dhr) is no longer applicable as device was manufactured in 2009.Investigation result does not implicate a service process.The device was received for evaluation; in good condition.Device was manufactured in 2009.Powered on the device and activated actuator pole it started to spin and was noisy.This confirmed the reported issue.The root cause of the issue was deemed to be normal wear and tear.Action(s) taken to mitigate the reported issue(s): replaced actuator pole, drain valve and float switch; installed disposables and tempcheck test fixture; powered on the device and performed 30 minute heat check and measured temperature within tolerance; checked all disposables/ tubes alarms.Device passed all functional and electrical tests.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15638137
• Report Number: 3012307300-2022-25351
• Device Sequence Number: 12229275
• Product Code: BSB
• UDI-Device Identifier: 50695085812904
• UDI-Public: 50695085812904
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: BK940056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: H-1129
• Device Catalogue Number: H-1129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown