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

Catalog Number DI-50

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

Patient Problem Ischemia (1942)

Event Date 09/06/2021

Event Type  Death  

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.G5: premarket (510k) number is unknown.

Event Description

It was reported that several air bubbles were noticed within the infusion line during surgery and the device did not alarm.The patient died intraoperatively shortly after.The patient's condition was already massively unstable at the beginning of surgery due to ischemia of the entire small intestine.At the time the air bubbles were seen, they knew the patient would not have survived anyway.Patient was treated during the ongoing anesthesia with desflurane at the time of the questioned air infusion and a massive catecholamine therapy for hemodynamic instable.

• Brand Name: LEVEL 1 TRAUMA FAST FLOW DISPOSABLES
• 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: 17010549
• MDR Text Key: 316018294
• Report Number: 3012307300-2023-05740
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DI-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• 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
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 70
• Patient Ethnicity: Non Hispanic
• Patient Race: White