MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-23 for GEMSTAR NON-DEHP TUBING PUMP SET-SL 13265-01 manufactured by Abbott Labs.
[343920]
Home care pt was properly taught by home care nurse to prime iv tubing for use in gemstar infusion pump. While priming, pt experienced large bubbles of air accumulation in tubing distal to the filter. Tubing was reprimed to remove air. Pump started. After a few mins of infusing, air again accumulated in the tubing distal to the air-eliminating filter. Over the next few days, several other pts and several different nurses all experienced the same problem. Rptr made the decision to stop using hospira iv tubings with the in-line 1. 2 micron filter until investigation by mfr solves the problem. Hospira rep came to office and was able to replicate the problem. She reported problem to hospira as well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1033838 |
| MDR Report Key | 563188 |
| Date Received | 2004-11-23 |
| Date of Report | 2004-11-23 |
| Date Added to Maude | 2005-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEMSTAR NON-DEHP TUBING PUMP SET-SL |
| Generic Name | IV TUBING W/1.2MICRON INLINE FILTER |
| Product Code | FRA |
| Date Received | 2004-11-23 |
| Model Number | 13265-01 |
| Catalog Number | 13265-01 |
| Lot Number | 09069 5H AND OTHERS |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 552916 |
| Manufacturer | ABBOTT LABS |
| Manufacturer Address | * NORTH CHICAGO IL 60064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2004-11-23 |