FDA Adverse Event
Malfunction
Summary report: N
PROVIDER 5500
MDR report key: 328584
·
Received April 23, 2001
Report
- Report Number
- 2024064-2001-00034
- Event Type
- Malfunction
- Date Received
- April 23, 2001
- Date of Event
- March 1, 2001
- Report Date
- March 21, 2001
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- MEA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
REPORT RECEIVED FROM ABBOTT INTERNATIONAL AFFILIATE (ABBOTT IRELAND) OF AN UNREQUESTED BOLUS DOSE DELIVERY. THE REPORT STATES: "UNREQUESTED BOLUS DOSE DELIVERED". IT WAS NOT KNOWN IF THERE WAS AN ADVERSE PT EVENT AS A RESULT OF THE UNREQUESTED BOLUS DOSE. THE PUMP SETTINGS WERE NOT KNOWN. THE DEVICE IS EXPECTED TO BE RETURNED TO AN ABBOTT-OWNED FOREIGN SERVICE CENTER FOR TESTING AND INVESTIGATION. CO HAS REQUESTED ADDITIONAL INFO. NO FURTHER INFO HAS BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18541 | PROVIDER 5500 | INFUSION PUMP | MEA | ABBOTT LABORATORIES | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |