MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for FUSION HOLLOW FIBER OXYGENATOR BB811 manufactured by Perfusion Systems.
[183104416]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183104417]
Medtronic received information that during use of a fusion oxygenator it was noted that there was decreased flow. No problems were reported during priming and at the start pump ran with full flow possible with normal pressures. Immediately afterwards there was decreasing flow. Rpm's were increased, after minute flow decreased, the perfusionist then increased rpm's but saturation declined. At max rpm but perfusionist could not turn more than 2. 2 liter. Arterial pressure after oxy was 120mmhg. Negative pressure max 10mmhg suction. Saturation patient continued to decline and anesthesiologist had to ventilate patient again. The device was replaced. There was no adverse effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2020-00014 |
| MDR Report Key | 9810599 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-02-10 |
| Date Added to Maude | 2020-03-10 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUSION HOLLOW FIBER OXYGENATOR |
| Generic Name | OXYGENATOR, CARDIOPULMONARY BYPASS |
| Product Code | DTZ |
| Date Received | 2020-03-10 |
| Model Number | BB811 |
| Catalog Number | BB811 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |