FDA Adverse Event
Malfunction
Summary report: N
SMISSON-CARTLEDGE BIOMEDICAL, LLC
MDR report key: 12668484
·
Received October 20, 2021
Report
- Report Number
- 3006158088-2021-00002
- 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) MEDICAL CENTER FOR A MASS BLOOD TRANSFUSION. DURING THE PROCEDURE, THE HOSPITAL STATED THE CASSETTE STARTED LEAKING FROM THE BOTTOM OF THE CASSETTE. THE HOSPITAL IMMEDIATELY SWITCHED TO PRESSURE BAGS. THE PATIENT WAS TAKEN TO THE OR WHERE A SECOND THERMACOR UNIT WAS USED. DUE TO THE LOCATION OF THE LEAK, IT APPEARS THE HOSPITAL STAFF POSITIONED THE TUBE INCORRECTLY IN THE ROLLER PUMP WHICH CAUSED THE PINCHED TUBING AND LEAKAGE. THE RETAIN SAMPLE WAS TESTED AND NO ISSUE WAS NOTED. NO ISSUE HAS BEEN NOTED FOR THIS LOT OF CASSETTES IN THE FIELD. THE CASSETTE WAS NOT RETURNED BY THE HOSPITAL WHICH NO FURTHER INVESTIGATION COULD BE PERFORMED ON THE LEAKING CASSETTE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1564466 | SMISSON-CARTLEDGE BIOMEDICAL, LLC | THERMACOR 1200 INFUSION SYSTEM | FRN | SMISSON-CARTLEDGE BIOMEDICAL, LLC | PTC-1200 | 316833 | 00857893006059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |