MAUDE Adverse Event Report: MEDELA AG THOPAZ+ PUMP W/ AC ADAPTOR (1; PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)

Model Number 0791000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Tachycardia (2095); Increased Respiratory Rate (2486)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

Medela (b)(4) spoke with the clinical practice manager (cpm) at the hospital, who indicated that on 02/25/2020 they had spoken with the rotation nurse after being made aware of the incident.The rotation nurse explained that the covering nurse initially heard beeping from the thopaz+ device and saw an error message, which instructed to turn the device off/on or call for support.The covering nurse turned the device off and back on twice and the beeping stopped.The device was in use on the patient during this time.At some point later, the patient rang the hospital call bell for assistance.The rotation nurse went into the room and heard the beeping and saw the error and made arrangements to get a replacement thopaz+ device from the operating room.Once the patient was switched over to the replacement device, he stabilized and was doing well.The critical care team and respiratory therapist were all informed that the patient was okay.The doctor was notified and made aware of the incident.Evaluation of the device by the manufacturer is pending and results/analysis will be reported in a follow up filing.

Event Description

On 02/25/2020, a customer reported to medela (b)(4) that a thopaz+ device was in use on a patient when the patient called a nurse into his hospital room, alleging that he couldn't breathe.The nurse found that the thopaz+ pump was reporting an internal error and that it was beeping.The patient experienced shortness of breath ++, with tachycardia and a respiratory rate of 26.The patient stated that he felt as if he was going to "code." oxygen was applied for comfort.The critical care team was called, as well as a respiratory therapist.A chest x-ray, ekg, and vbg (venous blood gas) were performed.

Manufacturer Narrative

The device was received by the medela canada service center and a review of the log file identified that internal failures were present.The service technician replaced the main board and vent valve and cleaned the device.After the servicing, the pump passed a functional pressure test.Because the device was serviced by medela canada and returned to the customer, it could not be evaluated by medela ag, the legal manufacturer.The main board and vent valve which had been replaced were sent to medela ag; however, because cushioning material was not added to protect the components during transport from canada to switzerland, the components were not evaluated as damage could have occurred during transport.Medela ag did, however, extract the log file from the main board.Several alarms and warnings were identified, which provided evidence that the motor was likely not turning.However, a final conclusion could not be drawn by medela ag.While in use on the patient, the device displayed an internal error and audibly alarmed before permanent failure, as intended, as designed and as described in the instructions for use.

• Brand Name: THOPAZ+ PUMP W/ AC ADAPTOR (1
• Type of Device: PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED)
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug,
• MDR Report Key: 9883803
• MDR Text Key: 195642681
• Report Number: 1419937-2020-00027
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• PMA/PMN Number: K130210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0791000
• Device Catalogue Number: 0791000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Date Manufacturer Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization