MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO CDI 500 BLOOD PARAMETER MONITOR

Model Number 500AVHCT

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the user stated the alarm did not go off on the blood parameter monitor (bpm) when pt's saturated venous oxygen (svo2) dropped below 60%.The device was not changed out.The surgical procedure was completed successfully.There was a slight one to two minute delay due to the perfusionist (ccp) trying to identify the issue.There was no blood loss nor adverse consequence to the pt.Per the clinical review on (b)(6) 2015: the complaint report states there was a delay in the procedure, but there was no delay (per subsidiary site) just a delay of the ccp in using the bpm (during troubleshooting).According to the user, they had the low limit for svo2 set at 65% but when the measure dropped below 65% there was no low level alert posted on the bpm unit.The user claims that they had the low alert limit set to 65%, but when the svo2 dropped below 65% (and there was no expected low alert messaging), they were surprised even though they claim they did not set it to that level.It is not known at this time if there is an issue with the monitor or was accidentally set back to 60% by one of the users.This issue has not occurred on later cases and the svo2 low limit alert has remained at 65%.The case was completed successfully without delay of the surgical procedure.There was no associated blood loss and no harm was reported.

Manufacturer Narrative

Upon checking the settings again, it was said that the usual settings were reverted back to default setting.

Manufacturer Narrative

The reported complaint was not verifiable.As the unit has been working without issue, the customer does not want to return the monitor to the manufacturer for evaluation.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: TERUMO CDI 500 BLOOD PARAMETER MONITOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4574743
• MDR Text Key: 5546994
• Report Number: 1828100-2015-00210
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K972962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,company repres
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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 Operator: Health Professional
• Device Model Number: 500AVHCT
• Device Catalogue Number: 500AVHCT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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