MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-14 for TRANSPAC IV MONITORING KIT 42648-06 manufactured by Icu Medical, Inc..
[179422386]
Patient arrived from or with arterial line tubing that did not have a safeset. Tubing was changed out to above tubing. After it was connected, there was no waveform on the monitor. Line still drew blood and flushed without issue. Immediately after zeroing the line there would be a waveform for approximately 3-4 beats and then it would go flat and read (?? /?? ). Alternate pressure cable was tried with no change in reading. A-line tubing was again changed out and waveform was immediately present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9711042 |
| MDR Report Key | 9711042 |
| Date Received | 2020-02-14 |
| Date of Report | 2019-12-09 |
| Date of Event | 2019-12-03 |
| Report Date | 2019-12-09 |
| Date Reported to FDA | 2019-12-09 |
| Date Reported to Mfgr | 2020-02-14 |
| Date Added to Maude | 2020-02-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSPAC IV MONITORING KIT |
| Generic Name | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR |
| Product Code | DRS |
| Date Received | 2020-02-14 |
| Model Number | 42648-06 |
| Lot Number | 3780101 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | 951 CALLE AMANECER SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |