FDA Adverse Event
Injury
Summary report: N
COMPAT ENTERAL DELIVERY SYSTEM
MDR report key: 1695780
·
Received May 18, 2010
Report
- Report Number
- 2110851-2010-00002
- Event Type
- Injury
- Date Received
- May 18, 2010
- Date of Event
- April 16, 2010
- Report Date
- May 3, 2010
- Manufacturer
- NESTLE HEALTHCARE NUTRITION, INC.
- Product Code
- LZH
- PMA / PMN Number
- K891575
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER REQUESTED DEVICE BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
RN INSTALLED THE SET INTO THE PUMP AT 7:00 PM, AND IS NOT CERTAIN IF THE SET WAS PROPERLY INSTALLED IN GUIDE. THE CERTIFIED NURSING ASSISTANT FOUND THE TUBING WAS PULLED OUT OF THE TUBING GUIDE ON THE PUMP AND 1500 CC WAS DELIVERED IN APPROXIMATELY 1.5 HOUR A TIME FRAME. PATIENT WAS SENT TO HOSPITAL FOR TREATMENT FOR ASPIRATION AND DID RESPIRATORY THERAPY IN HOSPITAL. PATIENT RETURNED TO NURSING HOME FIVE DAYS AFTER INCIDENT FULLY RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPAT ENTERAL DELIVERY SYSTEM | PRODUCT CODE LZH ENTERAL FEEDING PUMP | LZH | NESTLE HEALTHCARE NUTRITION, INC. | 199235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |