MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-08-22 for PLUM XLM SINGLE CHAN 11859 manufactured by Abbott Laboratories.
[300277]
Report received of a patient receiving an over-delivery of cardizem. The device was programmed to deliver a 100ml bag of cardizem at a rate of 10ml/hr. The customer could not recall the infusion start time. It was reported that the nurse left the patient's room and approximately five minutes later the pump alarmed that the infusion was complete. The customer had no specific patient information; however, it was reported that the patient's vital signs remained stable and no medical interventions were required. Though requested, no additional patient information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921482-2003-00442 |
| MDR Report Key | 480732 |
| Report Source | 05 |
| Date Received | 2003-08-22 |
| Date of Report | 2003-08-05 |
| Date of Event | 2003-08-01 |
| Date Mfgr Received | 2003-08-05 |
| Device Manufacturer Date | 1998-09-01 |
| Date Added to Maude | 2003-09-02 |
| 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 | 0 |
| Manufacturer Contact | THOMAS SAMPOGNA, ASSOCIATE DIR |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 389 BLDG. J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479353715 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 755 JARVIS DRIVE |
| Manufacturer City | MORGAN HILL CA 95037 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95037 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLUM XLM SINGLE CHAN |
| Generic Name | INFUSION PUMP |
| Product Code | KDZ |
| Date Received | 2003-08-22 |
| Returned To Mfg | 2003-08-18 |
| Model Number | NA |
| Catalog Number | 11859 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 469586 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 755 JARVIS DR. MORGAN HILL CA 95037 US |
| Baseline Brand Name | PLUM XLM SINGLE CHAN |
| Baseline Generic Name | INFUSION PUMP |
| Baseline Model No | NA |
| Baseline Catalog No | 11859 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-08-22 |