MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PNEUPAC¿ DISPOSABLE PATIENT CIRCUIT; VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)

Catalog Number	122003
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	Bradycardia (1751); Hyperventilation (1910)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.
Event or Problem Description
It was reported that a pneupac¿ patient circuit was in use with a ventilated patient on a portable ventilator when it was observed that the circuitry tubing and the portable ventilator were connected incorrectly.The device issue occurred in a hospital during a computerized tomography (ct) scan.It was noted that it was unclear which end of the tubing should be connected to a given valve.The device had to be disconnected, which caused the patient to decompensate during transport.The patient began "'gasping' for breaths" and developed bradycardia of 30-40bpm.The patient was "manually [bagged]" and also placed on a 100% fio2 portable ventilator and returned to an intensive care unit room, where the patient was reconnected to a ventilator.No permanent injury was reported.The event was considered resolved.
Additional Manufacturer Narrative
Two pneupac¿ disposable patient circuits were returned for investigation.One of the devices was returned outside its original packaging and with a peep adaptor which was not included the pneupac¿ disposable patient circuit kit.The second device was received inside its original unopened packaging (lot 019727-1-3).Visual inspection found no damage to either returned circuit.Additionally, it was noted that both disposable patient valves had a clear arrow along with the word "patient" on both sides which indicated which connection goes towards the patient.The device instructions for use (ifu) were included in the pneupac¿ disposable patient circuit kits.The device ifu illustrated the correct assembly of the circuit as well as stated that pre-use checks were to be completed, as per the ventilator user manual, prior to patient use.The incorrect assembly of the circuit would have been highlighted during the pre-use check as the manometer would not have provided the correct reading when the output port on the patient valve was occluded due to the gas being able to escape through the patient valve, exhalation exhaust port.No fault was identified with the returned circuits and all both circuits were found to be correct.It was determined that the root cause of the reported issue was due to the user failing to operate the equipment in accordance with the device ifu.

• Brand Name: PNEUPAC¿ DISPOSABLE PATIENT CIRCUIT
• Common Device Name: VENTILATOR, EMERGENCY, POWERED (RESUSCITATOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6403560
• Report Number: 3012307300-2017-00705
• Device Sequence Number: 634923
• Product Code: BTL
• UDI-Device Identifier: 10610586046063
• UDI-Public: 10610586046063
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 122003
• Device Lot Number: 019727-1-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 04/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 73