FDA Adverse Event
Malfunction
Summary report: N
ALARIS SE PUMP ADMINSTRATION SET
MDR report key: 1901337
·
Received November 10, 2010
Report
- Report Number
- 9616066-2010-00327
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 11, 2010
- Report Date
- September 15, 2010
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K931550
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER'S REPORT DATE: 11/10/2010. (B)(4). THE SET WAS RECEIVED AND FUNCTIONAL TESTING CONFIRMED THE CRACK AND LEAK IN THE ACCUSLIDE BASE; ROOT CAUSE WAS IDENTIFIED AS ENVIRONMENTAL STRESS CRACKING. THE REPORT OF THE CASSETTE BEING DIFFICULT TO LOAD COULD NOT BE CONFIRMED OR REPLICATED WITH THE SET BEING INSTALLED A TEST DEVICE.
Description of Event or Problem · 1
CUSTOMER REPORTED ACCUSLIDE ON SET CRACKED LENGTHWISE AND LEAKED A BOTTLE OF MEDICATION ON THE FLOOR. STAFF REPORTED THE CASSETTE FELT TOO BIG AND WAS, THEREFORE, DIFFICULT TO LOAD AND CRACKED ON INSERTION. THERE WAS NO HARM TO THE PT. NO ADDITIONAL INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS SE PUMP ADMINSTRATION SET | FPA | CAREFUSION CORPORATION | 10013182 | 10046344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | SN UNK| SE INFUSION PUMP |