MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-22 for ALARIS EXTENSION SET 20029E manufactured by Carefusion.
[124665068]
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[124665109]
The customer reported that during an infusion of remodulin (hanging for less than 24 hours), leaking was noticed at the extension set and filter. The tubing was changed and it leaked again. There was no report of patient harm.
Patient Sequence No: 1, Text Type: D, B5
[130694560]
The customer? S report of leaking was confirmed. Visual inspection of the set including use of magnification did not reveal any damage or abnormalities. Functional testing confirmed leaking at the connection between the suspect set? S proximal female luer and the concomitant extension set's distal male luer. It was observed that the connection between the sets was not fully tightened. Dimensional analysis results were within specification. The root cause of the leaking was the connection between the suspect and concomitant set not being fully tightened.
Patient Sequence No: 1, Text Type: N, H10
[130694561]
The customer reported that at 14:00 during an infusion of remodulin 10mcg/ml in 30ml of diluent, at a rate of 0. 96ml/hr for less than 24 hours, leaking was noticed at the extension set and filter. The tubing was changed and it leaked again at 16:00. Both leaks were at the engagement of the tubing and the filter. The patient was previously intubated with continuous monitoring and continued to have desaturations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2018-01999 |
| MDR Report Key | 7992596 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-22 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-09-27 |
| Date Added to Maude | 2018-10-22 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ADE AJIBADE |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214386 |
| Manufacturer Phone | 8586172000 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 921214386 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALARIS EXTENSION SET |
| Generic Name | SET, EXTENSION, INTRAVASCULAR |
| Product Code | FPB |
| Date Received | 2018-10-22 |
| Returned To Mfg | 2018-11-27 |
| Model Number | 20029E |
| Catalog Number | 20029E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 921214386 US 921214386 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-22 |