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It was reported that pressure was being placed on the flexiport cuff connector of a flexiport disposable cuff attached to ge & phillips monitors (no welch allyn devices in use) and inaccurate readings of multiple patients occurred.The customer alleges that the events were in the procedure/or setting/ pain room with allegations of patient¿s receiving unnecessary treatment of artline placement, medications, transfer of care to the er, and delayed care.It is noted by the customer that pressure was likely placed on the flexiport connector due to surgical positioning (tucked at sides for procedures) or cuff placement on the patient.The customer additionally stated that the cuffs are sometimes being leaned on during procedures (typically breast procedures) and when cuffs are being used on the right arm of the patient, the artery index marker is not aligned with the brachial artery and the flexiport connector is being placed under the patient¿s arm.This event has been captured under hillrom complaint ref # (b)(4).
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The customer reported one incident where a patient received unnecessary medication/treatment; however, the customer was unable to conclude which device was being used at the time of the event.The customer noted three potential devices.As it is unable to be determined which suspect device may have caused or contributed to the event, hillrom is reporting an mdr for each device involved.The additional two mdrs have been submitted under 1316463-2022-00135 and 1316463-2022-00136.Welch allyn pediatric through adult blood pressure cuffs are noninvasive blood pressure cuffs intended for use in conjunction with non-automated and automated sphygmomanometers to determine blood pressure in pediatric through adult patients.The welch allyn flexiport disposable blood pressure cuffs are a reliable disposable cuff solution.This is a single patient use model.Multiple follow-up attempts were made with the customer, however, they have not provide further details of the initial alleged harm/injury associated with the device, including: number of patients with involved injuries, date of injures, sequence of events, medical intervention provided, length of delay allegations, device sizes & injury associated with each patient, and additional patient information including admitting diagnoses, past medical history, gender, age and weight, and each patient¿s outcome.The device ifu notes the following warnings: possible measurement error.Use only approved blood pressure cuffs and accessories; substitution might result in measurement error.Warning: inaccurate measurement risk.Only use the cuff when the artery index marker falls within the printed range indicated on the cuff, otherwise erroneous readings may result.Warning: patient injury risk.Never install luer lock connectors on welch allyn blood pressure tubing.Using these connectors on blood pressure cuff tubing creates the risk of mistakenly connecting this tubing to a patient¿s intravenous line and introducing air into the patient¿s circulatory system.Warning: do not apply cuff to areas on patient where skin is delicate or damaged.Check cuff site frequently for irritation.Warning: allow space for 1 to 2 fingers between patient and cuff.Warning: do not apply cuff to limbs used for iv infusion.Warning: minimize cuff movement and limb motion during readings.Warning: ensure an airtight seal at all connection points prior to use.Per the welch allyn flexiport blood pressure cuffs comparison tests with non-welch allyn monitors document (attached via the dl of the complaint): hillrom has conducted several rounds of comparative studies on various manufacturer's competitive monitors (including ge and philips monitors) to show that there are no statistically significant differences in readings between welch allyn flexiport cuffs and cuffs that ship as original equipment on the non-welch allyn devices.There are two accepted methods used to obtain an automated non-invasive blood pressure; the auscultatory method in which the device uses a microphone in the cuff to listen for korotkoff sounds as the cuff is deflated and the oscillometric method in which the device measures the strength of the oscillations against the cuff generated by pulsatile blood flow beneath the inflated cuff.It is generally acknowledged that all automated nibp devices will occasionally provide a reading the clinician determines to be questionable.Artifact is a major contributor to questionable readings, or the inability to provide a reading.Bp readings can vary by 10 - 40 mmhg on the same patient due to patient factors including but not limited to measurement, location on the body, changes in blood pressure over time, psychological and physical stressors, and body posture.Therefore, the clinician would assess the patient and attempt to distinguish if the abnormal readings were actual or due to the above-mentioned variables that can affect the readings.Because of this, in line with clinical recommendations for assessing vital signs, clinicians do not rely solely on a single blood pressure reading for determining a clinical treatment plan.When faced with suspect readings, clinicians can determine if a patient has an acute variation in blood pressure based on medical history, physical assessment as well as reported symptomatology and can seek an alternative back-up sphygmomanometer to validate a result.The hillrom sales representative scheduled customer in-servicing/ training to provide proper application of the cuffs and faqs on blood pressure measurement (finding attached via the dl of the complaint).The customer has replied that they do not have specific patient information to provide for this complaint, just the multiple incidences provided, along with the cuff sizes were used.They did not save the cuffs used on patients involved in this complaint.As noted above, multiple attempts to gain further information from the customer has been unsuccessful.It is reasonable to conclude if medications were adjusted as reported, the clinician would base medication type and dosages on a series of readings, patient¿s medical history as well as patient assessment.The patients would also be cautiously observed by nurses and physicians at the facility for therapeutic effects, the patient¿s response to any medication adjustments and would be unlikely to lead to serious injury or death.Additionally, if the care team had concerns with a bp taken using the oscillometric method, then the ausculatory method would be used (as noted in the ifu and customer noted to have occurred in a few of the events) to compare and determine inaccuracy.This may cause a slight delay; nevertheless, it would be minimal and should be completed/confirmed prior to a patient going to a higher level in care.However, due to the reported invasive procedure of an artline placement this would be considered a serious injury.An arterial line is a thin catheter inserted into an artery.Arterial lines are most commonly used in intensive care medicine and anesthesia to monitor blood pressure directly and in real-time (rather than by intermittent and indirect measurement).The event was likely due to misuse of the device as it was noted by the customer that staff received no education prior to implementation, at times cuff placement on the patient was not used with proper technique and during procedures (with patient arms tucked) they stated additional pressure was placed with surgical staff leaning on the arm.These events likely impacted the ability for the blood pressure cuff bladder to inflate appropriately, and therefore led to inaccurate readings.Procedures for prevention of this type of event are outlined per the ifu as noted above.However, due to the reported invasive procedure of an artline placement, hillrom considers this a serious injury and therefore reportable.
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