FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ PUMP
MDR report key: 1231098
·
Received October 30, 2008
Report
- Report Number
- 2921482-2008-00348
- Event Type
- Malfunction
- Date Received
- October 30, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 7, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K052052
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE DURING AN ALARM CONDITION. THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED IV SOLUTION. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AFTER AN UNSPECIFIED TIME, IT WAS NOTED THAT THE DEVICE DISPLAY INDICATED THAT THE DELIVERY WAS COMPLETE; HOWEVER, THE DEVICE DID NOT SOUND AN AUDIBLE ALARM TONE INDICATING THE DELIVERY WAS COMPLETE. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PLUM A+ PUMP | 80-FRN | FRN | HOSPIRA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |