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

Model Number 5001102

Device Problems Leak/Splash (1354); Failure to Prime (1492)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

There are no devices of this lot remaining in inventory for analysis.Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.

Event Description

The hospital perfusionist reported an issue encountered with the mps delivery set during priming.He reported that the delivery set was leaking on the lower half of the heat exchanger.The perfusionist stated it appeared to be a failure in the bonding of the two pieces.As a result, the delivery set was changed out for another prior to use in the surgery.There were no patient complications reported as a result of the alleged event.The device was returned to the manufacturer for analysis.

Manufacturer Narrative

The customer originally reported the lot to be 0494465u07, but upon examination of the returned device along with manufacturing records, the lot was for 0495215u11.The complaint sample analysis found that the uv bond was inadequate.Because heat exchangers are 200% leak-tested and any rejects are automatically sorted from the lot, it is unlikely this device had passed leak testing.The automatic robot function was not working during this time.The rejected devices were being manually sorted by the operators.It is most likely th eoperator mixed this device with the good parts/placed in the incorrect bin.

• Brand Name: MPS DELIVERY SET
• Type of Device: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 5208847
• MDR Text Key: 30688438
• Report Number: 1649914-2015-00097
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• 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 faci
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/30/2015

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: Other
• Device Expiration Date: 07/12/2018
• Device Model Number: 5001102
• Device Lot Number: 0494465U07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2015
• 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