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Quantum PureFlow Standard Heat Exchanger Low Flow 1/4
SPECTRUM MEDICAL SRL · Model HX11W-S1 · UDI-DI 08051160301201
DTR
Prescription
3
510(k) clearances
858
Adverse events (6 deaths)
33
Recalls
33
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-18 | Maquet Medical Systems USA | 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and c |
| 2019-12-17 | Quest Medical, Inc. | Additive and Arrest Agent Labels on the MPS Top Cover Replacement Kit, a replacement for worn or damaged MPS Console Top Covers for cardiopulmonary bypass heat exchanger, used to d |
| 2015-10-28 | Quest Medical, Inc. | The products have been found to intermittently exhibit a seal failure during use. |
| 2014-01-31 | Maquet Cardiovascular Us Sales, Llc | The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger |
| 2011-03-01 | Terumo Cardiovascular Systems Corp | Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line |
| 2011-03-01 | Terumo Cardiovascular Systems Corp | Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line |
| 2011-03-01 | Terumo Cardiovascular Systems Corp | Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line |
| 2010-07-29 | Quest Medical, Inc | User update regarding installation of external heater-Cooler units with MPS and MPS2 consoles. |
| 2010-06-08 | Terumo Cardiovascular Systems Corp | Vent port may be occluded and prevent delivery of fluid |
| 2010-06-08 | Terumo Cardiovascular Systems Corp | Vent port may be occluded and prevent delivery of fluid |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.