MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. PRESCRIPTIVE OXY PACK - CAPIOX; CIRCUIT CONNECTORS

Model Number 74284

Device Problem Connection Problem (2900)

Patient Problem Blood Loss (2597)

Event Date 05/11/2017

Event Type  Injury  

Manufacturer Narrative

Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references (b)(4).

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the quick connect popped off on the oxygenator outlet and sprayed blood everywhere.Blood loss of 300 ml, product was not changed out, procedure completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on june 2, 2017.(b)(4).Upon evaluation of the returned sample, it was found to function as intended.Connection testing and pressure testing of the returned sample found no anomalies or leaks from anywhere on the device.Inspection of the two quick connects confirmed no anomalies with the parts.The reported event was not able to be replicated; therefore, the complaint was not confirmed and a definitive root cause was not able to be determined.It is likely that the quick connects had not been properly connected during the setup of the circuit, causing them to be disconnected during use.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: PRESCRIPTIVE OXY PACK - CAPIOX
• Type of Device: CIRCUIT CONNECTORS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6607517
• MDR Text Key: 76505370
• Report Number: 1124841-2017-00100
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 74284
• Device Catalogue Number: N/A
• Device Lot Number: VD20
• Other Device ID Number: 00699753487710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other