MAUDE Adverse Event Report: WELCH ALLYN BP PORT FITTING,2-TUBE,LOCKING, 10/BG; SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Model Number 2-MQ

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/19/2021

Event Type  malfunction  

Event Description

Report received from the (b)(6) involving a flexiport 2-mq double lumen tube for blood pressure cuff.The customer reported the coupling broke resulting in an air leak and the inability to continuously measure the patient¿s blood pressure during transport for suspected stroke.Per the report, measurement of the patient¿s blood pressure would have been indicated and relevant based on the suspected diagnosis and elevated blood pressure requiring treatment could have led to (further) damage to the brain (e.G., bleeding), which could lead to severe physical impairments such as hemiplegia.There was no report of patient injury or deterioration in patient condition associated with the reported malfunction.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

Hillrom has requested the device be returned to our service centre where it will be preliminarily inspected.The device will then be forwarded to the hillrom manufacturer for a thorough investigation.Hillrom has also requested further clarification of the patients' condition and the device that the connector was being used with.Hillrom will submit a final report with investigation conclusion on this incident no later than the 23-dec-2021.

Event Description

Report received from the swissmedic authority involving a flexiport 2-mq double lumen tube for blood pressure cuff.The customer reported the coupling broke resulting in an air leak and the inability to continuously measure the patient¿s blood pressure during transport for suspected stroke.Per the report, measurement of the patient¿s blood pressure would have been indicated and relevant based on the suspected diagnosis and elevated blood pressure requiring treatment could have led to (further) damage to the brain (e.G., bleeding), which could lead to severe physical impairments such as hemiplegia.There was no report of patient injury or deterioration in patient condition associated with the reported malfunction.Hillrom reached out to the customer for further information on the event and asked for the items involved in the event to be returned for investigation however the customer refused to provide further details and did not return the item in question back to the manufacturer but instead sent it to an unknown company procamed.Therefore no investigation into the reported malfunction could be performed.There was no report of patient injury or deterioration in patient condition associated with the reported malfunction.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

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.Welch allyn/hillrom blood pressure cuff is intended to be used by a clinically trained, medical professional.Prehospital management of a suspected stroke includes but is not limited to measurement of vital signs, obtaining a 12-lead ecg, establishing iv access, blood glucose analysis, and performing a pre-hospital stroke assessment scale to determine neurological deficit.Results of the field assessment would be provided to the receiving hospital to aid in triage, evaluation, and treatment of the patient.Treatment for stroke can involve the administration of thrombolytic therapy, which would only be done in the hospital.The focus of care by emergency medical service (ems) would be supporting airway, breathing, and circulation, cardiac monitoring, and rapidly transporting the patient to the nearest hospital or stroke center.In the event a failure occurred with the automated blood pressure cuff and/or its components, ems would likely have a back-up manual blood pressure cuff on board to monitor blood pressure.The customer declined to provide further information regarding the reported event.The ifu of the flexiport cuff states: "inspect cuff for deterioration and adequate closure integrity, and then inflate to assess for leaks.Do not use if you identify any abnormalities in the cuff." a single parameter nibp failure that occurs during active monitoring of the patient's bp would cause the device to attempt reinflation multiple times.A trained clinician would recognize that the machine was unable to inflate and assess for causes for no reading and use their knowledge and clinical skills to determine the urgency of obtaining the patient's blood pressure.If other causes cannot correct the issue after troubleshooting, a clinician would immediately recognize that the device was unable to provide a nibp measure due to the damage, the ring disconnecting from the cuff, and would likely remove it from clinical service until the device is repaired or replaced.If the device were to be unavailable for use, the clinician would obtain a backup device, which may result in a delay.Such delays are brief and would not result in significant risk to the patient.If a backup was not available, the clinician could perform a manual blood pressure reading.There was no report of patient injury or deterioration in patient condition associated with the reported malfunction and it is unlikely the malfunction could contribute to a serious injury or death if it were to recur.However due to the nature of the event occurring in an ambulance where the user has not confirmed if they had any other device or means available to measure the blood presure, hillrom is cautiously reporting this event and deeming it in absence of any further information of possibility to investigate as a reportable event at this point in time hillrom cannot determine the cause of the reported malfunction due to insufficient information provided by the customer and the affected item not being returned to hillrom for investigation.At this time hillrom has not received any similar complaints and therefore will track this reported event for any possible future trends and will then act accordingly.Based on the information above no further action is required at this time.

• Brand Name: BP PORT FITTING,2-TUBE,LOCKING, 10/BG
• Type of Device: SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: sarah oreilly ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 12821882
• MDR Text Key: 285263706
• Report Number: 1316463-2021-00076
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 00732094015140
• UDI-Public: 732094015140
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2-MQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1