MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-11-16 for PALL "LIPIPOR" TNA FILTER TNA1E manufactured by Pall Newquay.
[127460521]
The tna1e filter associated with this incident was not retained by the user. The investigation is underway; currently we are awaiting the hospital to confirm additional occurrence details. Our findings will be "pulblished", target for completion january 4th, 2019.
Patient Sequence No: 1, Text Type: N, H10
[127460522]
The customer reported to pall that air was observed downstream of a pall lipipor tna filter (tna1e), lot# 18-839. It was indicated that during administration, it was noted that the total volume of the parenteral bag (500ml) was distributed in 6 hours, as opposed to the normal distribution of 200ml in 14 hours. On (b)(6) the infusion line was disconnected from the child patient. Before the second reconnection, the nurse saw bubbles in the filter extension and then in the filter. Clinical consequences observed: hyperthermia, tachycardia, respiratory distress, hyperglycemia, then hypoglycemia. Actions undertaken: change of tubing, filter, and infusion pump. Note: implicated reorder code tna1e is not registered and sold in the us. All fda information below relates to a "like" product, reorder code tna1, which is registered for sale in the us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680602-2018-00005 |
| MDR Report Key | 8080716 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-16 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-19 |
| Date Added to Maude | 2018-11-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RICHARD BORELLI |
| Manufacturer Street | 25 HARBOR PARK DRIVE |
| Manufacturer City | PORT WASHINGTON NY 11050 |
| Manufacturer Country | US |
| Manufacturer Postal | 11050 |
| Manufacturer Phone | 5168019639 |
| Manufacturer G1 | PALL NEWQUAY |
| Manufacturer Street | ST. COLUMB MAJOR IND EST |
| Manufacturer City | ST. COLUMB MAJOR, TR9 6TT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | TR9 6TT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL "LIPIPOR" TNA FILTER |
| Generic Name | INTRAVENOUS FILTER |
| Product Code | FPB |
| Date Received | 2018-11-16 |
| Model Number | TNA1E |
| Lot Number | 18-839 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALL NEWQUAY |
| Manufacturer Address | ST. COLUMB MAJOR IND EST ST. COLUMB MAJOR, TR9 6TT UK TR9 6TT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-16 |