FDA Adverse Event
Malfunction
Summary report: N
PLUM A+ PUMP
MDR report key: 1182344
·
Received September 22, 2008
Report
- Report Number
- 2921482-2008-00299
- Event Type
- Malfunction
- Date Received
- September 22, 2008
- Date of Event
- August 1, 2008
- Report Date
- September 2, 2008
- Manufacturer
- HOSPIRA, INC.
- Product Code
- FRN
- PMA / PMN Number
- K052052
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 THE PT RECEIVED MORE IV FLUID THAN INTENDED. THE PUMP WAS PROGRAMMED TO DELIVERY NORMAL SALINE AT A RATE OF 75 ML/HR WITH A VOLUME TO BE INFUSED (VTBI) OF 1000 ML AND THE DELIVERY WAS STARTED. THE CUSTOMER CONTACT REPORTED THAT APPROX 2.5-3 HOURS AFTER THE INITIATION OF THE DELIVERY, THE CONTAINER WAS REPORTEDLY EMPTY. THERE WERE NO ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING TESTING AT THE USER FACILITY, THE PUMP DELIVERED MORE THAN INTENDED. 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 | 67 YR | PLUM A+ SOFTWARE MODULE |