MAUDE Adverse Event Report: UNKNOWN TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Accessory Incompatible (1004); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Description

Since "xxxxxxxx," our approximately 450 bed hospital has received at least 28 cases of omitted or wrong time errors due failure to unclamp the secondary iv line tubing.So far, the most severe one reported was a k phos that wasn't infused, which resulting in a decreased phos level the next day.My concern is that this may happen on a first dose antibiotic in a septic patient.We use alaris pumps, which does notify the rn to unclamp the line, but the pump does not alarm.We've tried various forms of education (several different newsletters, emails, shared learning documents, education by the alaris team, and are switching to shorter secondary tubing that may increase the visibility of the clamp.I'm at a loss for what else to do.Respondents shared error types that they have encountered despite the use of smart infusion pumps.The most common types of errors reported involved secondary infusions, including delayed or omitted secondary infusions caused by a closed roller clamp, or secondary infusions that were administered at the wrong rate.Even with technology, human error was still reported: programming errors due to dose-rate confusion.Decimal points.And drug selection: iv line or channel m, ix -ups; tubing misconnections: wrong drug: and wrong patient.Practitioners also reported frustrations with a time-consuming and complex programming process, including difficulties finding the correct drug when scrolling through a large list of generic names and overly sensitive and false alarms.(b)(6).Submission id (b)(4).

• Brand Name: TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12634025
• MDR Text Key: 277351460
• Report Number: MW5104623
• Device Sequence Number: 2
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1