DEGLYCE/CELL WASH SET, 275 ML 00235-00

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-01-11 for DEGLYCE/CELL WASH SET, 275 ML 00235-00 manufactured by Haemonetics Corp.

Event Text Entries

[64607768] One bag sample was returned to haemonetics for evaluation. The evaluation is still in progress. A supplemental report will be sent once the evaluation results are available.
Patient Sequence No: 1, Text Type: N, H10


[64607769] Haemonetics received a report from a customer on (b)(6) 2016 stating that a planned intra-uterine transfusion had to be canceled due to two red cell bags leaking after centrifugation. These red cell bags had been de-glycerolized utilizing the haemonetics? Acp? 215 device. The customer then took the bag and centrifuged it in order to concentrate the rbcs to a hematocrit of 0,70-0,85. The centrifugation of the bags is not a step in the de-glycerolization process that haemonetics outlines in the acp? 215 operator's manual. The customer stated that the leaks were not observed until after they had centrifuged the bags. The intra-uterine transfusion was required as the mother has an alloimmunization to erythrocyte antigens which is passed over the placenta and may cause anemia in the fetus. The two best matched erythrocyte units were contained in the two bags that leaked delaying the transfusion to the fetus, so the gynecologist decided to postpone the transfusion because there were no other completely matched units available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219343-2017-00002
MDR Report Key6243024
Report SourceFOREIGN,USER FACILITY
Date Received2017-01-11
Date of Report2016-12-13
Date of Event2016-12-02
Date Mfgr Received2016-12-13
Device Manufacturer Date2016-06-04
Date Added to Maude2017-01-11
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 ContactMS JULIE SMITH, RN
Manufacturer Street400 WOOD RD
Manufacturer CityBRAINTREE MA 02184
Manufacturer CountryUS
Manufacturer Postal02184
Manufacturer Phone7819170643
Manufacturer G1HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.
Manufacturer StreetCALLE COLINAS NO. 11731 SECC. INDUSTRIAL EL FLORIDO
Manufacturer CityTIJUANA, 22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDEGLYCE/CELL WASH SET, 275 ML
Generic NameDEGLYCE/CELL WASH SET, 275 ML
Product CodeKSW
Date Received2017-01-11
Returned To Mfg2016-12-29
Model Number00235-00
Catalog Number00235-00
Lot Number0616070
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHAEMONETICS CORP
Manufacturer Address400 WOOD RD BRAINTREE MA 02184 US 02184


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2017-01-11

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