FDA warn ’ s Getinge ’ s Datascope about ongoing IABP issues

The FDA recently revealed a warning letter it sent to  Getinge‘s (PINK:GETI B) Datascope over ongoing issues uncovered during an inspection of its Mahwah, N.J.-based intra-aortic balloon pump production facilities last year, noting a number of continuing quality and validation issues that have not yet been appropriately managed. The federal watchdog said that it has received responses to the originally noted violations, but noted several issues in which the responses did not adequately address. In its first noted violation, the FDA dinged the company for a failing to perform design validation that includes production unit testing in actual or simulated use conditions. The agency said that Datascope failed to develop a suitable test method for its Cardiosave IABP to “demonstrate the assembly of the new top cover protects against saline ingress in order to ensure only safe and effective devices are produced,” according to the warning letter. The FDA added that it also failed to show that the Cardiosave devices “passed the appropriate dielectric strength, leakage current tests, and whether it showed no signs of wetting of uninsulated electrical parts that could result in the loss of basic safety or essential performance in normal condition.” The federal watchdog said that it received a response on the matter, but that it “did not address” the specific violations. The agency also noted that Datascope failed to evaluate user need...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Datascope Corp. Getinge Source Type: news

Related Links:

Publication date: Available online 6 April 2020Source: Colloids and Surfaces A: Physicochemical and Engineering AspectsAuthor(s): Yi Ding, Li Jia, Qi Peng, Jian Guo
Source: Colloids and Surfaces A: Physicochemical and Engineering Aspects - Category: Chemistry Source Type: research
ACS Applied Materials&InterfacesDOI: 10.1021/acsami.9b21438
Source: ACS Applied Materials and Interfaces - Category: Materials Science Authors: Source Type: research
.
Source: British Journal of Neurosurgery - Category: Neurosurgery Authors: Source Type: research
Condition:   Nocturia Due to Nocturnal Polyuria Intervention:   Drug: Desmopressin Sponsor:   Ferring Pharmaceuticals Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Abstract Intrauterine infections with the pathogens, including toxoplasmosis, other (syphilis, varicella, mumps, parvovirus, and HIV), rubella, cytomegalovirus, and herpes simplex (TORCH) in susceptible individuals during pregnancy, result in microcephaly, white matter disease, cerebral atrophy, and calcifications in the fetus. Pseudo-TORCH syndrome is an umbrella term, consisting of several syndromes, resultant from different genetic alterations and pathogenetic mechanisms. Band-like calcification with simplified gyration and polymicrogyria (BLC-PMG) is one of these conditions, resultant from biallelic mutations ...
Source: European Journal of Medical Genetics - Category: Genetics & Stem Cells Authors: Tags: Eur J Med Genet Source Type: research
Duplex systems can be complicated by reflux, ureterocele, obstruction (most commonly PUJ in a lower moiety) and wetting secondary to an ectopic ureteric insertion in girls. The decision making algorithm for selection of surgical approach is complex and there is no consensus. The authors described the outcomes following an upper urinary tract approach in 2011(1) and now compare these results in a similar group of patients managed using a lower approach.
Source: Journal of Pediatric Urology - Category: Urology & Nephrology Authors: Source Type: research
Publication date: Available online 27 March 2020Source: Materials LettersAuthor(s): Ivan Mazilkin, Kristina Tsoy, Alexander Straumal, Alexey Rodin, Brigitte Baretzky
Source: Materials Letters - Category: Materials Science Source Type: research
Phys. Chem. Chem. Phys., 2020, Accepted Manuscript DOI: 10.1039/D0CP00906G, PaperMichael Zharnikov, Mustafa Sayin, Alexei Nefedov Biorepulsivity of oligo(ethylene glycol) (OEG) substituted self-assembled monolayers (SAMs), serving as model systems for analogous polymeric surfaces, is generally ascribed to the hydration effect. In this context, we applied temperature-programmed... The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Phys. Chem. Chem. Phys. latest articles - Category: Chemistry Authors: Source Type: research
Phys. Chem. Chem. Phys., 2020, Accepted Manuscript DOI: 10.1039/D0CP00143K, PaperSanchari Bhattacharjee, sandip khan Aqueous ionic liquids are of particular interest due to their tunability of physical and chemical properties and a deeper understanding of their structure-property relationship is desired. Molecular dynamics (MD) simulations... The content of this RSS Feed (c) The Royal Society of Chemistry
Source: RSC - Phys. Chem. Chem. Phys. latest articles - Category: Chemistry Authors: Source Type: research
Environmental concerns have driven scientists to research new eco-friendly approaches for the preparation of nanosystems. For this purpose, novel bio-polymers have been selected. Among these, one of the most promising is lignin, which is biodegradable and biocompatible. Additionally, lignin is one of the main by-products of the paper industry and can be re-used in nanosystems building. Lignin-based nanosystems could be used in agriculture, to improve the uptake of bioactive compounds, thus avoiding soil pollution. However, the mechanism of penetration in the plant and the route of transportation within the internal plant t...
Source: European Journal of Histochemistry - Category: Biomedical Science Source Type: research
More News: Bed Wetting | Cardiology | Enuresis | Heart | Warnings