MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06 report with the FDA on 2014-09-05 for MONITORING KIT W/03ML FLUSH DEVICE 46010-34 manufactured by Icu Medical, Inc..
[4856100]
Fda/medsun report received concerning ae/pt event where one 46010-34 mtg kit and ecmo/oxygenator set-up was in use. It was reported that attending clinicians performed. " routine 12 hr flush and zeroing of the ecmo circuit pressure lines. Immediately after zeroing line on venous side of ecmo circuit and releasing pigtail stopcock, ecmo rns noted air on venous and arterial side of oxygenator of the ecmo circuit. Rn immediately clamped the lines. Code team summoned. Pt bagged and prolonged resuscitation including chest compressions and arrest meds occurred while pt was recannulated and converted to vena arterial ecmo. Pt remained critical. Parent requested that we withdraw treatment. Patient expired". The "preliminary cause of death is ards. Autopsy being performed. " additionally the medsun report states "how air got into the circuit is not known at this time. The tubing remained visually intact and did not "fall apart". There have been no previous issues with the tubing at this facility. The ecmo machine did not alarm: air was detected by the two ecmo rns before the air reached the ecmo circuit.
Patient Sequence No: 1, Text Type: D, B5
[12334705]
Follow up information received reports: "mtg kit was initially placed approx (b)(6) 2014 when that circuit was likely built. No issues were found during priming; it was primed under emergency circumstances. No abnormalities during circuit checks were noted. The recorded data in the emr leading up to the event shows no abnormalities in the charting either. '' the medsun report indicates that facilities post incident assessment of the 46010-34 monitoring kit components did not identify any component abnormalities and or defects. The facility's internal investigation/assessments did not identify any potential product and or component issues with the concomitant devices, equipment and or mating and access devices. "the only thing found was that the barrel on the luer lock was found to be loose, which we believe led to a break in the seal of the monitoring tubing from the transducer itself. Under negative pressure, this provides a means for air entry into the circuit, which fits with the described scenario. " device return: used ecmo set-up returned, consisting of partial segments of the 46010-34 monitoring kit along with maquet adult oxygenator unit; additional unknown mfrs. Ecmo tubing lines; manifold, needle free connectors, syringes and stop-cocks. Decontamination and engineering analysis are in progress. Preliminary conclusion: the exact and/or potential cause of this event are unknown at this time. The 46010-34 mtg kit was successfully in use for approx 16 days with no functional or performance issues. It is unclear and cannot be determined as to whether the references to loose "luer lock" connection occurred during the "routine q12 hr flush and zeroing of the ecmo circuit pressure lines or "loosened" during the described emergent code activities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2025816-2014-00106 |
| MDR Report Key | 4072632 |
| Report Source | 00,05,06 |
| Date Received | 2014-09-05 |
| Date of Report | 2014-07-03 |
| Date of Event | 2014-06-26 |
| Date Facility Aware | 2014-06-26 |
| Report Date | 2014-07-03 |
| Date Reported to Mfgr | 2014-08-07 |
| Date Mfgr Received | 2014-08-07 |
| Date Added to Maude | 2014-09-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY SCESNY |
| Manufacturer Street | 4455 ATHERTON DRIVE |
| Manufacturer City | SALT LAKE CITY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012641400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONITORING KIT W/03ML FLUSH DEVICE |
| Generic Name | MONITORING KIT |
| Product Code | OES |
| Date Received | 2014-09-05 |
| Returned To Mfg | 2014-09-04 |
| Model Number | 46010-34 |
| Catalog Number | 46010-34 |
| Lot Number | UNK |
| ID Number | PR# 26815 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | SALT LAKE CITY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-09-05 |