Infusion Pumps

Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.

Fetal patient report was automatically pulling prior measurement data for a prior fetus since the fetal study is based on the mother's MRN, resulting in the wrong fetal measurements getting referenced.

Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.

St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiation may restart from the beginning instead of recalculating the field based on the already delivered dose.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the communication between enGen TCAutomation (TCA) Bypass modules (manufactured by Thermo-Fisher Scientific) and the VITROS Analyzers. To date, no occurrences of this issue have been observed on Orthos enGen(TM) Systems. Sample IDs may become miss-associated with the actual sample being processed due to discrepant information passed to the analyzer through InOut communication device, triggered by a specific set of events occurring between the Bypass module and the analyzer. --- All of the following conditions must be present for the issue to potentially occur: (1.) The Bypass module is in the process of positioning Sample A at the aspiration position, and (2.) At least two additional sample tubes (Samples B and C) are waiting to be aspirated in the Bypass module queue, and (3.) A Radio Frequency Identification (RFID) Tag Read failure occurs on the Sample A carrier, and (4.) The VITROS System is not available to aspirate on the track (for example, the analyzer is initializing, or the user is making entries on the diagnostic screen, or samples are being aspirated from the front of the analyzer, etc.). --- If the software anomaly occurs and the issue is present, the Sample ID in the INOUT communication device software queue becomes asynchronous with the actual Sample ID physical queue, and the VITROS assay result will be reported for the wrong Sample ID. All subsequent samples will have miss-associated results until the Bypass module is reset or the queue is empty. --- This issue could potentially miss-associate a sample/patient ID with a test result of a different sample. Depending on the test involved, patients health condition, etc., the potential health risk posed to the affected patient could range from no risk to serious risk, and potentially could lead to misdiagnosis or inappropriate medical intervention. To date, no patient harm was reported related to this product issue.

Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.

Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam customization, and may lead to a discrepancy in dose calculation between this version of Mobius3D (1.5.0) and the prior version (1.4.2), where none should have been expected.

Some eyelets broke from SwiveLock Anchor on insertion.