FDA Adverse Event
Other
Summary report: N
ACCLAIM ENCORE
MDR report key: 241747
·
Received September 17, 1999
Report
- Report Number
- 2921482-1999-00208
- Event Type
- Other
- Date Received
- September 17, 1999
- Date of Event
- August 9, 1999
- Report Date
- August 24, 1999
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- FRN
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
OVERDELIVERY REPORTED. THE PUMP WAS TO BE SET TO INFUSE DOBUTAMINE 500MG/250ML AT 18-32ML/H. USER FACILITY REPORTS: "IV PUMP PROGRAMMED WRONG. ONE BAG OF DOBUTAMINE INFUSED FROM 08/09 1300-1645. SECOND BAG INFUSED FROM 08/09 1645 TO 2015. THIRD BAG INFUSED FROM 08/09 2015 TO 08/10 0230. FOURTH BAG INFUSED CORRECTLY FROM 08/10 0230 -1000. DOBUTAMINE 250ML BAG AT 32ML/H WOULD INFUSE OVER 7.5 HOURS." THE NATURE OF THE PROGRAMMING ERROR WAS NOT SPECIFIED; HOWEVER, THE REPORTER INDICATES IT MAY HAVE BEEN A ML/H VERSUS MCG/KG/MIN DOSING ERROR. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. NO ADD'L INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCLAIM ENCORE | INFUSION PUMP | FRN | ABBOTT LABORATORIES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |