FDA Adverse Event
Injury
Summary report: N
CLEARSTAR PUMP
MDR report key: 1062902
·
Received June 19, 2008
Report
- Report Number
- 1527460-2008-00831
- Event Type
- Injury
- Date Received
- June 19, 2008
- Date of Event
- May 11, 2008
- Report Date
- May 20, 2008
- Manufacturer
- ROSS PRODUCTS DIVISION
- Product Code
- LZH
- PMA / PMN Number
- K981541
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RECEIVED IN HOUSE AND IS CURRENTLY UNDER EVALUATION.
Description of Event or Problem · 1
THE COMPLAINANT REPORTED THAT THE TUBE-CLAMP WAS CLOSED, BUT THE PUMP GAVE NO ALARM OVER SEVERAL HOURS. IT WAS REPORTED THAT A PT WAS NOT FED FOR SEVERAL HOURS. THE PT DEVELOPED HYPOGLYCEMIA (BLOOD GLUCOSE WAS <49 MG/DL). IT IS UNK IF ANY OTHER SIGN OR SYMPTOMS OCCURRED IN THIS CASE. THE HEALTH CARE PROVIDER GAVE THE PT GLUCOSE AND THE PT'S CONDITION IMPROVED (BLOOD SUGAR 136 MG/DL).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLEARSTAR PUMP | LZH PUMP, INFUSION, ENTERAL | LZH | ROSS PRODUCTS DIVISION | 55239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |