MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-30 for ENTERALITE INFINITY ENTERAL FEEDING PUMP INFKIT2 manufactured by Moog Medical Devices Group.
[185665151]
The pump was not returned to mmdg for evaluation. A dhr review was completed and found no non-conformances. Because the pump was not returned mmdg was not able to investigate or confirm the complaint. This report will be updated if the pump is returned to mmdg.
Patient Sequence No: 1, Text Type: N, H10
[185665152]
The initial reporter stated that the formula was backing up into tubing. They stated that the administration set was correctly placed, but did not provide any additional information. Mmdg made multiple attempts to follow up and obtain additional information, but those attempts were not successful. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722139-2020-00106 |
| MDR Report Key | 9898210 |
| Report Source | CONSUMER |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2011-12-05 |
| Date Added to Maude | 2020-03-30 |
| 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 | 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 FEEDING PUMP |
| Generic Name | ENTERAL INFUSION PUMP |
| Product Code | LZH |
| Date Received | 2020-03-30 |
| Model Number | INFKIT2 |
| Catalog Number | INFKIT2 |
| Lot Number | N/A |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-30 |