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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS2 CONSOLE; CPBP HEAT EXCHANGER
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QUEST MEDICAL, INC. MPS2 CONSOLE; CPBP HEAT EXCHANGER Back to Search Results
Model Number 5201260
Medical Device Problem Codes Sticking (1597); Positioning Problem (3009)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 07/24/2017
Type of Reportable Event Malfunction
Event or Problem Description
The perfusionist reported an issue encountered with the mps2 console during use.The report stated the console had displayed the error code for "excess air in hex" and had to be manually clamped.There were no patient complications reported as a result of the alleged issue.A field service engineer will evaluate the console at the user's facility.
 
Additional Manufacturer Narrative
The device was evaluated and some unknown substance was found around the edge of the fluid level sensor causing it to stick and not make contact with the heat exchange.The fluid level sensor was replaced.
 
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Brand Name
MPS2 CONSOLE
Common Device Name
CPBP HEAT EXCHANGER
Manufacturer (Section D)
QUEST MEDICAL, INC.
one allentown parkway
allen TX 75002
MDR Report Key6809372
Report Number1649914-2017-00063
Device Sequence Number969666
Product Code DTR
UDI-Device Identifier20634624521265
UDI-Public20634624521265
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K041979
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 11/28/2017
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
Operator of Device Other
Device Model Number5201260
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/24/2017
Supplement Date Received by Manufacturer07/24/2017
Initial Report FDA Received Date08/21/2017
Supplement Report FDA Received Date11/28/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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