B/F WARM SET HIGH FLOW CE D25330CE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08,distributor report with the FDA on 2015-07-10 for B/F WARM SET HIGH FLOW CE D25330CE manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[18658964] It was alleged that the meditemp fluid warmer cassette ruptured during use. It was alleged the cassette was primed in the usual manner with normal saline and then used to infuse blood into the patient as per hospital protocol. The cassette rupture occurred whilst the hospital staff were infusing blood into a patient. It was alleged the surgical procedures were delayed/prolonged due to the theatre staff having to locate another meditemp blood warmer and cassette and set up a new blood infusion for patient. It was alleged that prolonged recovery time for patient post operatively, due to delivery of blood at less optimal temperature.
Patient Sequence No: 1, Text Type: D, B5


[25505230] The investigation concluded that a likely cause for this issue is using a pump in series with the device creating a greater than specified pressure which contributed to the cassette leak.
Patient Sequence No: 1, Text Type: N, H10


[25505231] It was alleged that the meditemp fluid warmer cassette ruptured during use. It was alleged the cassette was primed in the usual manner with normal saline and then used to infuse blood into the patient as per hospital protocol. The cassette rupture occurred whilst the hospital staff were infusing blood into a patient. It was alleged the surgcial procedures were delayed/prolonged due to the theatre staff having to locate another meditemp blood warmer and cassette and set up a new blood infusion for patient. It was alleged that prolonged recovery time for patient post operatively, due to delivery of blood at less optimal temperature.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2015-00338
MDR Report Key4906932
Report Source08,DISTRIBUTOR
Date Received2015-07-10
Date of Report2015-07-06
Date of Event2015-07-02
Date Mfgr Received2015-07-06
Date Added to Maude2015-08-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRIAN THOMPSON
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693292100
Manufacturer G1STRYKER MEDICAL-KALAMAZOO
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal Code49002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameB/F WARM SET HIGH FLOW CE
Generic NameDEVICE, WARMING. BLOOD AND PLASMA
Product CodeKZL
Date Received2015-07-10
Catalog NumberD25330CE
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-10

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