MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2008-08-26 for CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET R4R9955 manufactured by Baxter Healthcare.
[931630]
The customer contacted company to report an adverse event that occurred with a pt who received blood product from a cryocyte freezing container. Transfusion was commenced using a pooled sample including two frozen/thawed cd34 selected products and five units of frozen/thawed donor original bone marrow. Total volume transfused was 660ml cd34 dose was 3. 67x106/kg. Dmso amount was 1. 14g/kg. The physician involved described this event as an adverse reaction to stem cell infusion/dmso, complicated by hypertensive crisis, subarachnoid hemorrhage, pulmonary edema, and acute renal impairment hemolysis. The pt has been stabilized but has a low white cell count and is still hospitalized. Per the attachments obtained from miltenyi biotec inc, there was no cryocyte container failure, defect or breakage involved with this incident. Add'l info received on 08/05/08 provided a timeline of the events which is as follows: 1130-infusion commenced, the pt experienced chest tightness, bp 130/80-160/110. Atenolol 25mg was given. At 1400, the infusion was completed. At 1445, the pt experienced hypoxia and had crackles in the left mid-zone of the lung. The bp was 220/120. The bp then dropped from 190/120 to 160/110. High dose oxygen support was given in addition to furosemide 40mg iv, amlodipine, and then furosemide 40mg iv once again. At 1500, the pt's urine was blood stained. At 1600, a chest x-ray showed patchy infiltration of both lower zones of the lungs. Methylprednisone was given 1mg/kg. The pt had a moderate headache. A ct of the brain showed extensive subarachnoid hemorrhage for which a platelet, rfactor vii transfusion was given. The pt's creatinine was 152umol/l, the ldh was 4010u/l, and the total bilirubin was 109umol/l.
Patient Sequence No: 1, Text Type: D, B5
[8108573]
The samples are not available for eval as they were discarded by the customer. Reportedly, there was no visible product defect on any of the cryocyte containers involved.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2008-00772 |
| MDR Report Key | 1136706 |
| Report Source | 01,05 |
| Date Received | 2008-08-26 |
| Date of Report | 2008-08-01 |
| Date of Event | 2008-06-23 |
| Date Mfgr Received | 2008-08-01 |
| Date Added to Maude | 2008-09-08 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY, MGR |
| Manufacturer Street | 25212 W. ILLINOIS RTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Street | 1900 HIGHWAY 201 NORTH |
| Manufacturer City | MOUNTAIN HOME AR 72653249 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 72653 2497 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYOCYTE FREEZING CONTAINER 500 ML W/LABEL POCKET |
| Generic Name | 81KSE |
| Product Code | KSE |
| Date Received | 2008-08-26 |
| Catalog Number | R4R9955 |
| Lot Number | H07I29029 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1163879 |
| Manufacturer | BAXTER HEALTHCARE |
| Manufacturer Address | MOUNTAIN HOME AR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-08-26 |