FDA Adverse Event
Injury
Summary report: N
ALARIS INFUSION SET
MDR report key: 1132085
·
Received August 21, 2008
Report
- Report Number
- 9616066-2008-00028
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- July 18, 2008
- Report Date
- August 1, 2008
- Manufacturer
- CARDINAL HEALTH ALARIS PRODUCTS
- Product Code
- FPA
- PMA / PMN Number
- K022209
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EXTENSION SET IS CONNECTED TO A PRIMARY TEST THAT IS USED TO INFUSE TPN SOLUTION. CUSTOMER REPORTED EXTENSION SET LEAKING AND CAUSED A DROP IN PT'S BLOOD SUGAR TO LESS THAN 40. PT REQUIRED TREATMENT WITH CONCENTRATED DEXTROSE SOLUTION. SET REQUESTED, BUT NOT RECEIVED. IF SET RECEIVED, A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS INFUSION SET | FPA, EXTENSION SET | FPA | CARDINAL HEALTH ALARIS PRODUCTS | 10011865 | 08065262 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MODEL # 10798696 |