MAUDE Adverse Event Report: HAEMONETICS CORP DEGLYCE/CELL WASH SET, 275 ML

Model Number 00235-00

Device Problem Leak/Splash (1354)

Patient Problem Anemia (1706)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Haemonetics received a report from a customer on 12/13/2016 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.

• Brand Name: DEGLYCE/CELL WASH SET, 275 ML
• Type of Device: DEGLYCE/CELL WASH SET, 275 ML
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C.; calle colinas no. 11731 secc.; industrial el florido; tijuana, 22244 ; MX 22244
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 6241735
• MDR Text Key: 64592837
• Report Number: 1219343-2017-00001
• Device Sequence Number: 1
• Product Code: KSW
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: BK060008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 00235-00
• Device Catalogue Number: 00235-00
• Device Lot Number: 0116063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• 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): Hospitalization