MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-07-11 for FLOW DETECTOR 01907 manufactured by Abbott Laboratories.
[57714]
Report of "free flow' of nitroglycerin received. The pump was being set up in the emergency department to administer a nitroglycerin infusion at 3 ml/hr. At initial setup, a nurse immediately noted a fast flow of fluid in the drip chamber. She stopped the flow, turned the device off/on, reset it for 3 ml/hr and restarted the infusion. The same scenario occurred. The device did not alarm, but the nurse reported she immediately intervened and may not have given the pump time to alarm. The pt experienced a drop in blood pressure from a baseline of 120-140/70 to 66/30. She was placed in the trendelenberg position and her blood pressure quickly returned to baseline. The pump was switched out and the same tubing worked fine in the new device. The pt was then transferred to the icu. Upon arrival in the icu, the device was alarming for "flow. " the icu nurse noted that the nitroglycerin was flowing too fast. The pt reportedly had another transient drop in blood pressure, but quickly recovered after the infusion was stopped. The tubing was switched out, and the new set was then used successfully with the second pump that was initiated in the er. There were no adverse sequelae reported.
Patient Sequence No: 1, Text Type: D, B5
[7766180]
Testing and investigation confirmed free flow with a returned set. The returned unused set tested ok. The flow detector tested ok. The pump was received with loose boards, however, when tested with a new set the unit passed all performance verification and long term tests within product specification. A defective administration set caused the free flow.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921482-1997-00122 |
| MDR Report Key | 104897 |
| Report Source | 05 |
| Date Received | 1997-07-11 |
| Date of Report | 1997-06-04 |
| Date of Event | 1997-06-04 |
| Date Facility Aware | 1997-06-04 |
| Report Date | 1997-06-04 |
| Date Mfgr Received | 1997-06-04 |
| Device Manufacturer Date | 1992-08-01 |
| Date Added to Maude | 1997-07-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOW DETECTOR |
| Generic Name | DROP DETECTOR |
| Product Code | FLN |
| Date Received | 1997-07-11 |
| Returned To Mfg | 1997-06-09 |
| Model Number | NA |
| Catalog Number | 01907 |
| Lot Number | 68-707-G1 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 103153 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 1212 TERRA BELLA REG NO: 2921482 MOUNTAIN VIEW CA 94043 US |
| Baseline Brand Name | FLOW DETECTOR |
| Baseline Generic Name | INFUSION PUMP ACCESSORY |
| Baseline Model No | NA |
| Baseline Catalog No | 01907 |
| Baseline ID | NA |
| Baseline Device Family | INFUSION PUMP |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K944190 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-07-11 |