FDA Adverse Event
Malfunction
Summary report: N
LEGACY CASSETTE
MDR report key: 12682351
·
Received October 21, 2021
Report
- Report Number
- MW5104892
- Event Type
- Malfunction
- Date Received
- October 21, 2021
- Report Date
- July 28, 2021
- Manufacturer
- SMITHS MEDICAL ASD, INC.
- Product Code
- LHI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
SPONTANEOUS. PT'S MOTHER REPORTED DEFECTIVE CASSETTE AND A SPIKE WITH A BROKEN AIR FILTER. NEITHER ITEM WERE USED BY THE PATIENT NO ADVERSE EVENT REPORTED. ITEMS ARE NOT AVAILABLE FOR INVESTIGATION. CASSETTE LOT NUMBER 4120063. NO FURTHER DETAILS PROVIDED. DID THE REPORTED PRODUCT FAULT OCCUR WHILE IN USE WITH THE PT? NO; DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY? NO; IS THE ACTUAL PRODUCT AVAILABLE FOR INVESTIGATION? NO; DID WE [MFR] REPLACE THE PRODUCT? YES; DID THE PT HAVE A BACKUP PRODUCT THEY WERE ABLE TO SWITCH TO? YES; WAS THE PT ABLE TO SUCCESSFULLY CONTINUE THEIR INFUSION? YES; IS THE INFUSION LIFE-SUSTAINING? YES. REPORTED TO (B)(6) BY PT/CAREGIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1572344 | LEGACY CASSETTE | SET, I.V. FLUID TRANSFER | LHI | SMITHS MEDICAL ASD, INC. | UNK | 4120063 | |
| 1572349 | MINI SPIKE DISP PIN | SET, I.V. FLUID TRANSFER | LHI | B. BRAUN MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |