MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500

Model Number	500AHCT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation is in progress, but not yet concluded the reported complaint was observed by comparing the readings with another bpm, as well as using external thermometer.The manufacturer's subsidiary's service technician did not find any errors by the first inspection, only a 'f00d' message.
Event or Problem Description
The service technician reported that during routine testing of the device at the manufacturer's subsidiary's service center, the blood parameter monitor (bpm) temperature measurements were constantly fluctuating and slightly lower than the actual temperature of the fluid.There was no patient involvement.
Additional Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the arterial blood parameter monitor (bpm) to differ considerably from room temperature as read with a multimeter.It was determined that the arterial bpm was the cause of the inaccuracy.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Common Device Name: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 9922392
• Report Number: 1828100-2020-00151
• Device Sequence Number: 3257849
• Product Code: DRY
• UDI-Device Identifier: 00886799001622
• UDI-Public: (01)00886799001622(11)170107
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K133658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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
• Operator of Device: Other
• Device Model Number: 500AHCT
• Device Catalogue Number: 500AHCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1