FDA Adverse Event
Injury
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 1053355
·
Received May 28, 2008
Report
- Report Number
- 9616066-2008-00017
- Event Type
- Injury
- Date Received
- May 28, 2008
- Date of Event
- April 24, 2008
- Report Date
- April 29, 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
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED.
Description of Event or Problem · 1
FACILITY REPORTED THAT PATIENT WAS ON NITROPRUSSIDE DRIP FOR HYPERTENSION. BP IMPROVED, THEN PUMP ALARMED (ALARM MESSAGE NOT KNOWN), AND BP ROSE TOO HIGH. NURSE OPENED DOOR OF THE DEVICE AND FOUND CHANNEL WET WITH SMALL HOLE IN TUBING NEAR UPPER FITMENT. USER SWITCHED TUBING AND BP QUICKLY CAME BACK TO PREVIOUS LEVELS WITH NO OTHER INTERVENTION AND NO LONG TERM EFFECT ON PATIENT. FACILITY SENT SET FOR INVESTIGATION BUT IT HAS BEEN LOST IN SHIPPING. WILL FILE FOLLOW-UP REPORT IF SET IS RECEIVED IN THE FUTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE ADMINISTRATION SET | FPN, ADMINISTRATION SET | FPA | CARDINAL HEALTH ALARIS PRODUCTS | 2420-0500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Life Threatening| R | ALARIS SYSTEM PCU AND LVP |