FDA Adverse Event
Malfunction
Summary report: N
SIGMA SPECTRUM INFUSION PUMP
MDR report key: 2625452
·
Received June 8, 2012
Report
- Report Number
- 1314492-2012-00098
- Event Type
- Malfunction
- Date Received
- June 8, 2012
- Date of Event
- April 23, 2012
- Report Date
- May 9, 2012
- Manufacturer
- SIGMA INTL.
- Product Code
- FRN
- PMA / PMN Number
- K042121
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REVIEW OF THE DEVICE HISTORY LOG SHOWS TWO OCCURRENCES OF AN IMPROPER SHUTDOWN WHILE OPERATING ON POWER SUPPLIED BY THE WIRELESS BATTERY. SIGMA¿S ENGINEERING INVESTIGATION IS IN PROGRESS. WHEN COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PUMP STOPPED WITHOUT USER INPUT WHILE DELIVERING NITROGLYCERIN TO A PT. THE USER STATED THAT THE PUMP DISPLAYED ¿MALFUNCTION¿. THE DEVICE WAS PROGRAMMED TO DELIVER 250 ML AT A RATE OF 1.5 ML/HR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIGMA SPECTRUM INFUSION PUMP | INFUSION PUMP | FRN | SIGMA INTL. | 35700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |