FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 1911425
·
Received November 17, 2010
Report
- Report Number
- 9616066-2010-00338
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- September 28, 2010
- Report Date
- September 29, 2010
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INVESTIGATION CONFIRMED THE HOLE AND LEAK. VISUAL INSPECTION NOTED A SMALL TEAR NEAR THE UPPER FITMENT MEASURING 0.0425 INCHES. MICROSCOPIC EXAM NOTED CRUSH MARKS ON THE UPPER FITMENT. ROOT CAUSE OF THE TEAR WAS NOT IDENTIFIED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SET HAD A TINY HOLE IN THE SILICONE SEGMENT AND LEAKED DURING AN INFUSION. THE SET HAD BEEN INFUSING MULTIPLE HRS PRIOR TO THE LEAK BEING NOTED. NO ADD'L INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | 2430-0500 | 10066039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |