MAUDE Adverse Event Report: OAKDALE LEVEL 1 TRAUMA FAST FLOW SYSTEMS; WARMER, THERMAL, INFUSION FLUID

Model Number H-1000

Device Problems Defective Alarm (1014); Air/Gas in Device (4062)

Patient Problems Ischemia (1942); Insufficient Information (4580)

Event Date 09/06/2021

Event Type  Death  

Event Description

Reporter stated the device was in use with a patient requiring surgery due to ischemia of entire small intestine.Reporter stated the patient was being treated for hemodynamic instability throughout the procedure.The reporter stated after 2 hours of surgery air bubbles were noted in the warming tubing (past the air detector) and reporter stated no alarm occurred.When reporter (physician) was asked about patient details, the reporter stated the patient later expired during surgery.An autopsy was performed.The reporter stated the autopsy showed air in patient's right ventricle but it was not confirmed whether this was a result of an air embolism.Reporter was not provided the cause of death information.The reporter stated the "patient prognosis was poor" and after 2 hours of surgery patient was "massively unstable" and would "not have survived anyway".The reporter has no further information available regarding the patient or event.With the available information from the reporter (physician) this report is being filed regarding the reported air visualized in tubing past the air detector (potential product problem).

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: LEVEL 1 TRAUMA FAST FLOW SYSTEMS
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): OAKDALE; 3350 granada ave n; oakdale MN 55128
• Manufacturer (Section G): NULL; 6000 nathan lane n; plymouth MN 55442
• Manufacturer Contact: jim vegel ; 3350 granada ave n; oakdale, MN 55128 ; 7633833310
• MDR Report Key: 12526914
• MDR Text Key: 273154840
• Report Number: 3012307300-2021-09589
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 50695085829506
• UDI-Public: 50695085829506
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H-1000
• Device Catalogue Number: H-1000-GE-230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 05/03/2023
• Supplement Dates FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATECHOLAMINE; DESFLURANE; LEVEL 1 IV FLUID WARMING SET, PART NUMBER DI-50; RINGERFUNDIN INFUSION BAG; CATECHOLAMINE; DESFLURANE; LEVEL 1 IV FLUID WARMING SET, PART NUMBER DI-50; RINGERFUNDIN INFUSION BAG
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White