FDA Adverse Event
Malfunction
Summary report: N
CLEARSTAR PUMP
MDR report key: 3130039
·
Received May 24, 2013
Report
- Report Number
- 1527460-2013-00051
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- April 24, 2013
- Report Date
- April 24, 2013
- Manufacturer
- ABBOTT NUTRITION - COLUMBUS
- Product Code
- LZH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).THE TESTING AND INVESTIGATION RESULTS DID NOT CONFIRM THE COMPLAINT OF UNDER-DELIVERY. THE PUMP DELIVERED AT +6.2% ACCURACY, WHICH IS IN SPECIFICATION.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE REPORTED, LIST NUMBER M771, IS AN ABBOTT PRODUCT THAT IS MARKETED INTERNATIONALLY, WHICH IS THE SAME OR SIMILAR TO A DEVICE, LIST NUMBER 55239, THAT IS MARKETED DOMESTICALLY. ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED AN UNDER-DELIVERY. THE INTENDED DELIVERY WAS 330 ML AT A RATE OF 110 ML/HOUR FOR 3 HOURS; HOWEVER, THE ACTUAL DELIVERY VOLUME WAS 50 ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231539 | CLEARSTAR PUMP | LZH | ABBOTT NUTRITION - COLUMBUS | M771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |