MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED FLOW & EMBOLI TUBE ID 1/2" X WALL 3/32" (OD 11/16/"); FLOW SENSOR

Model Number	H11XLD
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Perfusionist stated that they zeroed the arterial, safe, and venous flow probes prior to the start of the case.However, when they were getting ready to go on cpb, they noticed that the venous flow was reading 0.6 even though the venous occluder was fully occluded.The perfusionist confirmed they did not see volume entering the reservoir.After the case, the arterial line was manually clamped, and the venous line was clamped via the venous occluder.Despite the occluder being fully occluded, the venous flow was reading 1.13 lpm.Again, with no drainage.The perfusionist also stated that their safe flow bubble detector fired twice during the case and stopped the pump both times.Air was not observed and they went back on cpb by disabling the safe flow bubble.The serial number of the venous flow probe was (b)(6) and safe flow probe was (b)(6).
Additional Manufacturer Narrative
Manufacturer narrative awaiting conclusion of investigation.

• Brand Name: FLOW & EMBOLI TUBE ID 1/2" X WALL 3/32" (OD 11/16/")
• Common Device Name: FLOW SENSOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucetser, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 19699483
• Report Number: 3003073153-2024-00013
• Device Sequence Number: 11675893
• Product Code: DRY
• UDI-Device Identifier: 05060434420138
• UDI-Public: 05060434420138
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K110957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: H11XLD
• Device Catalogue Number: H11XLD
• Device Lot Number: H11XLD644
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLOW SENSOR ID 3/8" X WALL 3/32"H9XLM - (B)(6)
• Patient Sex: Unknown