FDA Adverse Event
Malfunction
Summary report: N
TRANSPAC TRIFURCATED MONITORING KIT, 60" TUBING, 3 3 ML FLUSH DEVICE, MICRODRIP
MDR report key: 10534623
·
Received September 15, 2020
Report
- Report Number
- 9617594-2020-00395
- Event Type
- Malfunction
- Date Received
- September 15, 2020
- Date of Event
- August 11, 2020
- Report Date
- August 17, 2020
- Manufacturer
- ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
- Product Code
- DRS
- UDI-DI
- 00840619030032
- PMA / PMN Number
- K061573
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
H10: THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. THE DEVICE HISTORY REPORT (DHR) FOR LOT NUMBER 3964739 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND.
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED. THE DEVICE IS NOT YET RECEIVED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED TWO TRANSPAC TRIFURCATED MONITORING KITS THAT DURING PRIMING, PART OF THE PRESSURE LINE DISCONNECTED WHERE IT SHOULD HAVE BEEN BONDED TO. THERE WERE NO ADDITIONAL INFORMATION PROVIDED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. THIS IS THE SECOND OF TWO EVENTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 997937 | TRANSPAC TRIFURCATED MONITORING KIT, 60" TUBING, 3 3 ML FLUSH DEVICE, MICRODRIP | TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT | DRS | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. | 3964739 | 00840619030032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IV FLUIDS, BAXTER| IV FLUIDS, BAXTER |