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 2018-07-13 for PALL ULTIPOR 25 BREATHING SYSTEM FILTER BB25G manufactured by Pall Newquay.
[114007675]
The investigation is underway. We are waiting for the hospital to confirm that they will be returning the implicated filter to pall for testing. Upon receipt the returned device will be evaluated and findings will be published, target for completion july 30th, 2018.
Patient Sequence No: 1, Text Type: N, H10
[114007676]
It was reported that a pall ultipor 25 breathing system filter was in use and after 20 minutes in theatre under standard low flow conditions, it was noticed that the required flow rate could not be delivered to the patient. After switching from laryngeal mask airway to endotracheal intubation, re-adjustment of ventilator settings, the patient reanimation was started, which was possible after the filter was removed. The hospital has reported to pall that the patient is in icu, at this stage the prognosis is unknown. The patient is under mechanical ventilation and not responsive. The lot number of the one implicated filter is not known, but the hospital believes that the filter could be from one of the last three deliveries that they received. Those deliveries were filters from lot numbers 731202 (date of manufacture 07 november 2017), 805202 (date of manufacture 21 february 2018) and 810402 (date of manufacture 16 april 2018). The hospital did also inform pall that the tubing used in the breathing circuit is reprocessed (washing, disinfection, air-drying). The hospital have retained the filter. They are waiting for agreement from bfarm before returning the filter to pall for investigation. Note: implicated reorder code bb25g is not registered and sold in the us. All fda information below is related to "like" products, under 510k k791307, which are registered for sale in the us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680602-2018-00004 |
| MDR Report Key | 7686638 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-13 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-06-22 |
| Date Added to Maude | 2018-07-13 |
| 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 ULTIPOR 25 BREATHING SYSTEM FILTER |
| Generic Name | BREATHING FILTER |
| Product Code | CAH |
| Date Received | 2018-07-13 |
| Model Number | BB25G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-07-13 |