MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-16 for ENTERALITE INFINITY ENTERAL INFUSION PUMP INFKIT2 manufactured by Moog Medical Devices Group.
[184048078]
This device was returned to mmdg for evaluation. Based on the original complaint information, there was no indication of a reportable malfunction. During the investigation the pump under infused at a rate that mmdg considers reportable. The motor assembly had failed, which caused the under infusion.
Patient Sequence No: 1, Text Type: N, H10
[184048079]
The initial reporter stated that the pump had cosmetic damages. They stated that this occurred during testing and did not effect on a patient. When the pump was returned to mmdg for investigation it was found that the pump was infusing at a rate that mmdg considers reportable. [complaint-(b)(4)].
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2020-00092 |
| MDR Report Key | 9835783 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-16 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2016-06-29 |
| Date Added to Maude | 2020-03-16 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN HARDESTY |
| Manufacturer Street | 4314 ZEVEX PARK LANE |
| Manufacturer City | SALT LAKE CITY, UT |
| Manufacturer Country | US |
| Manufacturer Phone | 2641001112 |
| Manufacturer G1 | MOOG MEDICAL DEVICES GROUP |
| Manufacturer Street | 4314 ZEVEX PARK LANE |
| Manufacturer City | SALT LAKE CITY, UT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENTERALITE INFINITY ENTERAL INFUSION PUMP |
| Generic Name | ENTERAL INFUSION PUMP |
| Product Code | LZH |
| Date Received | 2020-03-16 |
| Returned To Mfg | 2020-03-13 |
| Model Number | INFKIT2 |
| Catalog Number | INFKIT2 |
| Lot Number | N/A |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOOG MEDICAL DEVICES GROUP |
| Manufacturer Address | 4314 ZEVEX PARK LANE SALT LAKE CITY, UT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |