FDA Adverse Event
Injury
Summary report: N
ALARIS PUMP MODULE IV ADMINISTRATION SET
MDR report key: 2212914
·
Received August 3, 2011
Report
- Report Number
- 9616066-2011-00445
- Event Type
- Injury
- Date Received
- August 3, 2011
- Report Date
- July 18, 2011
- Manufacturer
- CAREFUSION CORPORATION
- Product Code
- FPA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MFR'S REPORT DATE: (B)(4) 2011. (B)(4). ALTHOUGH REQUESTED, THE INFUSION SET HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS, SHOULD THE DEVICE BE RECEIVED FOR EVAL.
Description of Event or Problem · 1
CUSTOMER REPORTED, "A SMARTSITE INFUSION SET WAS FOUND WITH A HOLE, DEPLETING THE ENTIRE VECURONIUM INFUSION AND PERHAPS CAUSING A CHANNEL ERROR. THE PT WAS WITHOUT THERAPEUTIC NEUROMUSCULAR BLOCKING AGENT AND PERHAPS THIS CONTRIBUTED TO A CRITICAL STATUS." CUSTOMER STATES THAT NO FURTHER PT/EVENT INFO IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALARIS PUMP MODULE IV ADMINISTRATION SET | FPA | CAREFUSION CORPORATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other | ALARIS PC UNIT: S/N UNK| ALARIS PUMP MODULE: S/N UNK |