MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-07-01 for PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL 11943 manufactured by Abbott Laboratories.
[16144889]
Report received of "many air bubbles" found below the cassette. In 2003 at 1930, the pump was programmed to deliver 25000 units of heparin in 250cc at an unspecified rate. The nurse checked the pump at 2000 and noted no issues. Two hours later, the nurse entered the room and found a "small puddle below the pump" and there were reportedly "many air bubbles below the cassette". No audible alarm was reported. The infusion was stopped. After an unspecified length of time, the infusion was resumed using a replacement pump and tubing set. There was no reported adverse patient effect and no medical interventions were required. Though requested, no further information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615050-2003-00117 |
| MDR Report Key | 469927 |
| Report Source | 05 |
| Date Received | 2003-07-01 |
| Date of Report | 2003-06-20 |
| Date of Event | 2003-06-13 |
| Date Mfgr Received | 2003-06-20 |
| Date Added to Maude | 2003-07-09 |
| 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 | 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 | P.O. BOX 212-3006 |
| Manufacturer City | BARREAL DE HEREDIA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL |
| Generic Name | ADMINISTRATION SET |
| Product Code | FPA |
| Date Received | 2003-07-01 |
| Model Number | NA |
| Catalog Number | 11943 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 458772 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | P.O. BOX 212-3006 BARREAL DE HEREDIA CS |
| Baseline Brand Name | PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL |
| Baseline Generic Name | ADMINISTRATION SET |
| Baseline Model No | NA |
| Baseline Catalog No | 11943 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-07-01 |