FDA Adverse Event
Malfunction
Summary report: N
ALARIS PUMP MODULE ADMINISTRATION SET
MDR report key: 3821566
·
Received January 15, 2014
Report
- Report Number
- 9616066-2014-00020
- Event Type
- Malfunction
- Date Received
- January 15, 2014
- Report Date
- December 19, 2013
- Manufacturer
- CAREFUSION CORP.
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INTERNAL FILE NO: (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WITH FAILURE INVESTIGATION RESULTS WILL BE SUBMITTED SHOULD THE DEVICE BE RETURNED FOR EVALUATION.
Description of Event or Problem · 1
CUSTOMER REPORTED CRACKING OF THE MALE LUER ON THE PRIMARY SET. STATED THEY NO LONGER USE THE DUAL CAP MALE LUER PROTECTORS, THE MALE LUERS ARE COVERED WITH STERILE END CAPS. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. THE CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40527 | ALARIS PUMP MODULE ADMINISTRATION SET | FPA | CAREFUSION CORP. | 2426-0500 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | STERILE END CAPS, MFR/MODEL/LOT # UNK| ICU MEDICAL MICROCLAVE, MODEL/LOT #UNK |