MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS® DELIVERY SET WITH 6 FT. DELIVERY TUBING; CPBP HEAT EXCHANGER

Model Number 5001102-AS

Device Problems Leak/Splash (1354); Nonstandard Device (1420); Failure to Prime (1492)

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

Event Date 10/28/2015

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 use.She reported that the delivery set was observed to be leaking during priming, prior to the start of the surgery.The delivery set was changed out prior to use during 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 returned complaint sample pump cassette was attached with air source and dunk tested in water to identified leak.The leaking was identified below the blood inlet bushing and delamination of weld seam area confirming complaint condition.Dhr records were reviewed for the same lot and no rejected devices or manufacturing issues were documented similar to this reported complaint condition.

• Brand Name: MPS® DELIVERY SET WITH 6 FT. DELIVERY TUBING
• 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: 5208856
• MDR Text Key: 30687496
• Report Number: 1649914-2015-00096
• 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: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/02/2018
• Device Model Number: 5001102-AS
• Device Lot Number: 0495525G02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2015
• 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