FDA Adverse Event
Malfunction
Summary report: N
EXTENSION SET
MDR report key: 2629941
·
Received June 21, 2012
Report
- Report Number
- 9616066-2012-00446
- Event Type
- Malfunction
- Date Received
- June 21, 2012
- Date of Event
- January 1, 2012
- Report Date
- June 7, 2012
- Manufacturer
- CHURCHILL MEDICAL SYSTEMS, INC.
- Product Code
- FPA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT WAS FILED BY THE DISTRIBUTOR: (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVAL HAS BEEN COMPLETED.
Description of Event or Problem · 1
CUSTOMER REPORTED THIS SET ALLOWING FLOW THAT IS FASTER THAN WHAT THEY SET IT FOR, INCLUDING CONTINUED DRIPPING WHEN THE FLOW REGULATOR IS TURNED COMPLETELY OFF. REPORTER STATES: "IT WAS CONNECTED TO THE DRIP LINE ON THE CARDIOPULMONARY BYPASS MACHINE." THERE WAS NO PT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADD'L EVENT OR PT INFO PROVIDED BY THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTENSION SET | FPA | CHURCHILL MEDICAL SYSTEMS, INC. | 43000E | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | CARDIOPULMONARY BYPASS MACHINE, MFR & MODEL UNK |