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

Model Number	5001102
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The international distributor ((b)(4)) reported an issue reported to them from their customer with an issue encountered with the mps delivery set during use.The report stated "the green tab of the stopcock was over rotated to the unusual position." the report also stated that when the clinical staff attempted to inject additive agent into additive cassette, the additive agent injected to the patient accidentally because the green tab of the stopcock was located in an opposite position.The report stated the clinical staff possibly confirm the direction of green tab carefully.As a result of the alleged issue, the clinical staff attempted to washout the additive agent which injected the patient body with using 2,000 ml of blood (blood and potassium).There were no patient complications reported as a result of the alleged issue.The device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Visual examination of the returned device found that the clear plastic of the housing that stops the stopcock handle had damage as if forceful pressure had been applied, causing the handle to rotate past the normal stop position.The alleged issue was caused by over-rotation of the stopcock handle.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: MPS DELIVELY SET
• Common Device Name: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6783799
• Report Number: 1649914-2017-00062
• Device Sequence Number: 1852657
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 5001102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention