MEDTRONIC TUBING PACK
Report
- Report Number
- 9612164-2019-04315
- Event Type
- Injury
- Date Received
- October 11, 2019
- Date of Event
- October 9, 2019
- Report Date
- November 19, 2019
- Manufacturer
- MEDTRONIC MEXICO
- Product Code
- DWF
- UDI-DI
- 00763000261863
- PMA / PMN Number
- K171308
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN ASSISTANT
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
UPDATED INFORMATION: THE CUSTOMER TEMPORARILY CLAMPED OFF THE PUMP, REMOVED THE BROKEN CONNECTOR AND ADDED A NEW PIGTAIL. THE PATIENT LOST 200 ML OF BLOOD AS A RESULT OF THE CONNECTOR COMING OFF. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INVESTIGATION CONCLUSION; AT THIS TIME ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, MEDTRONIC UNDERSTANDS THE CLIENT CONCERN AND IN ORDER TO ENSURE NO RE-OCCURRENCE CATALOG SPECIFICATION WAS UPDATED ADDING SILICON BANDS TO THE 1160282-507 ADAPTER AND THE 3/16 X 1/16 X 3 TUBING SOLVENT CONNECTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CUSTOM TUBING PACK THE CONNECTOR CAME OF THE TUBING. THE PACK WILL BE REPLACED. THE PATIENT REQUIRED A TRANSFUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 972570 | MEDTRONIC TUBING PACK | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS | DWF | MEDTRONIC MEXICO | TL10H15R2 | 218145037 | 00763000261863 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |