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.
[64592837]
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
[64592838]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2017-00001 |
| MDR Report Key | 6241735 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-01-11 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-12-02 |
| Date Mfgr Received | 2016-12-13 |
| Device Manufacturer Date | 2016-01-18 |
| Date Added to Maude | 2017-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JULIE SMITH, RN |
| Manufacturer Street | 400 WOOD RD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7819170643 |
| Manufacturer G1 | HAEMONETICS MEXICO MANUFACTURING, S. DE R.L. DE C. |
| Manufacturer Street | CALLE COLINAS NO. 11731 SECC. INDUSTRIAL EL FLORIDO |
| Manufacturer City | TIJUANA, 22244 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22244 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEGLYCE/CELL WASH SET, 275 ML |
| Generic Name | DEGLYCE/CELL WASH SET, 275 ML |
| Product Code | KSW |
| Date Received | 2017-01-11 |
| Returned To Mfg | 2016-12-29 |
| Model Number | 00235-00 |
| Catalog Number | 00235-00 |
| Lot Number | 0116063 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORP |
| Manufacturer Address | 400 WOOD RD BRAINTREE MA 02184 US 02184 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-01-11 |