MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS DELIVERY SET W AA; CPBP HEAT EXCHANGER

Model Number 5001102

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2014

Event Type  malfunction  

Event Description

Device 1 of 3.Ref: mfr reports 1649914-2014-00036 and 1649914-2014-00037.The hospital reported an issue with three separate mps disposable delivery sets (of different lots) during surgical procedures.The staff reported that in each instance the delivery set was missing a connector to the extension line, and in each instance the problem was discovered after the procedure had started while the pt was being connected to the heart/lung machine.It was reported that as a result there was an approximate 10 minute delay in each procedure while another delivery set was obtained.There were no pt complications reported as a result of the reported events.The devices were returned to the mfr for analysis.

Manufacturer Narrative

(b)(4).Quest medical, inc.Has limited info related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient' history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.

• Brand Name: MPS DELIVERY SET W AA
• Type of Device: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; allen TX
• Manufacturer Contact: amy clendening-wheeler ; one allentown pkwy.; allen, TX 75002 ; 9723326338
• MDR Report Key: 4012733
• MDR Text Key: 21527653
• Report Number: 1649914-2014-00035
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2017
• Device Model Number: 5001102
• Device Lot Number: 0461284F04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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): Required Intervention