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

Model Number 8002950

Device Problems Device Sensing Problem (2917); Temperature Problem (3022)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the device will turn on but will over temp and will stop flow.No patient injury was reported.

Manufacturer Narrative

Other, other text: additional event information received indicating no patient involvement (updated b5, h6).D5 and e4 are unknown, no information provided to date.

Event Description

Additional information was received which included there was no patient involvement.

Manufacturer Narrative

One (1) sample was returned for evaluation.The sample was received with a cracked return tube and the printed circuit board (pcb) presented with fluid ingression.Functional testing was performed.The printed circuit board (pcb) was damaged by fluid ingress from the cracked return tube.The printed circuit board (pcb) was replaced.Additional repairs were completed.Preventive maintenance was performed.The cracked return tube issue is a known issue; a notification was submitted an internal capa and occurrence is being monitored via trend analysis.If the occurrence of this issue increases significantly, additional corrective actions will be taken.

• Brand Name: LEVEL 1 FAST FLOW FLUID WARMER
• Type of Device: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• 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: 15163230
• MDR Text Key: 304629230
• Report Number: 3012307300-2022-14630
• 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,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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
• Date Returned to Manufacturer: 07/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1