FDA Adverse Event
Death
Summary report: N
LIFECARE PCA PLUS INFUSER
MDR report key: 850318
·
Received May 10, 2007
Report
- Report Number
- 2921482-2007-00163
- Event Type
- Death
- Date Received
- May 10, 2007
- Date of Event
- July 28, 1999
- Report Date
- April 12, 2007
- Manufacturer
- HOSPIRA, INC.
- Product Code
- MEA
- PMA / PMN Number
- k895710
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT IDENTIFIED BY SERIAL NUMBER; THEREFORE, IT WILL NOT BE RETURNED FOR INVESTIGATION. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.
Description of Event or Problem · 1
LITERATURE REPORT RECEIVED INDICATING AN OPERATOR ERROR IN PROGRAMMING THE DEVICE RESULTING IN A PATIENT DEATH. THE LITERATURE REPORT FROM INSTITUTE FOR SAFE MEDICATION PRACTICES (ISMP) MEDICATION SAFETY ALERT THAT STATES, "A RECENT FATALITY OCCURRED AFTER A PRACTITIONER MISPROGRAMMED THE DRUG CONCENTRATION FOR A LOADING DOSE OF MORPHINE." DATABASE REVIEW INDICATES THAT THIS IS MOST PROBABLY A DUPLICATE OF PREVIOUSLY SUBMITTED MANUFACTURER REPORT # 2921482-1997-00058.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFECARE PCA PLUS INFUSER | 80-FRN | MEA | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death | MORPHINE, MFR UNK |