FDA Adverse Event
Injury
Summary report: N
ALARIS PUMP MODULE
MDR report key: 3581526
·
Received January 9, 2014
Report
- Report Number
- 2016493-2013-00539
- Event Type
- Injury
- Date Received
- January 9, 2014
- Date of Event
- November 23, 2013
- Report Date
- December 13, 2013
- Manufacturer
- CARDINAL HEALTH 303, INC.
- Product Code
- FRN
- PMA / PMN Number
- K950419
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVAL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE INFUSION BAG EMPTIED FASTER THAN EXPECTED. THE TPN WAS ORDERED TO RUN AT 6MLS/HR. THE TPM BAG WAS HUNG AT 1800 AND THE BAG WAS EMPTY AT 0220; REPORTEDLY 300MLS INFUSED OVER 8.5 HOURS. ALTHOUGH REQUESTED, NO ADD'L PT OR EVENT INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14729 | ALARIS PUMP MODULE | FRN | CARDINAL HEALTH 303, INC. | 8100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 DA | Required Intervention | THERAPY DATE:| ALARIS PUMP MODULE ADMINISTRATION SET| ALARIS PC UNIT SN UNK| MODEL/LOT NUMBER UNK |