FDA Adverse Event Summary report: N

TUBING

MDR report key: 12634025 · Received October 13, 2021

Report

Report Number
MW5104623
Date Received
October 13, 2021
Report Date
December 15, 2020
Product Code
FPA
Report Source
Voluntary report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

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).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1526381 TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA

Patients

Seq Age Sex Outcome Treatment
1