FDA Adverse Event
Malfunction
Summary report: N
SMISSON-CARTLEDGE BIOMEDICAL, LLC
MDR report key: 12668508
·
Received October 20, 2021
Report
- Report Number
- 3006158088-2021-00003
- Event Type
- Malfunction
- Date Received
- October 20, 2021
- Date of Event
- September 24, 2021
- Report Date
- October 20, 2021
- Manufacturer
- SMISSON-CARTLEDGE BIOMEDICAL, LLC
- Product Code
- FRN
- UDI-DI
- 00857893006059
- PMA / PMN Number
- K052055
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
(B)(4)
Description of Event or Problem · 0
THE THERMACOR 1200 RAPID INFUSION SYSTEM WAS BEING USED AT (B)(6) FOR A MASS BLOOD TRANSFUSION. DURING THE PROCEDURE, THE HOSPITAL STATED THE 3 SPIKE SET SPIKE BECAME DISCONNECTED AND THE RN WAS REQUIRED TO CONTINUALLY RESPIKE. THE PROCEDURE WAS COMPLETED WITH NO EXTRA TIME ADDED TO THE SURGERY OR PATIENT INJURY NOTED. THE 3 SPIKE SET HAS NOT BEEN RETURNED BY THE HOSPITAL WHICH NO FURTHER INVESTIGATION COULD BE PERFORMED ON THE SPIKE DISCONNECTING. NO OTHER INFORMATION WAS PROVIDED BY THE HOSPITAL CONCERNING THE DISCONNECTION OF THE SPIKE. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES/TUBING SETS IN THE FIELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1565466 | SMISSON-CARTLEDGE BIOMEDICAL, LLC | THERMACOR 1200 INFUSION SYSTEM | FRN | SMISSON-CARTLEDGE BIOMEDICAL, LLC | PTC-1200 | 324574 | 00857893006059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |