MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-20 for AUTOLOG WASH KIT ATL2001 manufactured by Medtronic Mexico.
[182397783]
The complaint device is not available for assessment as it was discarded by the customer. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182397784]
Medtronic received information that during the first cycle (filling process) of an autolog washkit, the customer noted a? Speed error? On the autolog instrument and they reset the instrument. When restarted, the same issue occurred and the washkit was broken. They stopped the machine, clamped the pipe between the reservoir and washkit and the suction system for reservoir still worked. They removed the washkit, checked the error, cleaned (removed blood with antiseptic agent), checked the machine that it could work properly and changed the washkit. They had to waste the blood in the bowl, about 70-80 ml. The blood could not be returned to the patient. Information received on january 12th, 2020 stated that the patient needed a blood transfusion of around 2 units or 400 ml as a result of the reported malfunction. The patient received the transfusion at the end of the surgery. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[188431695]
Conclusion; no root causes were confirmed as a result of this investigation. The affected product could not be analyzed at design site. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2020-00332 |
| MDR Report Key | 9606809 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-20 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-12-18 |
| Date Mfgr Received | 2020-02-06 |
| Device Manufacturer Date | 2019-03-07 |
| Date Added to Maude | 2020-01-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC MEXICO |
| Manufacturer Street | AV. PASEO DEL CUCAPAH #10510 |
| Manufacturer City | TIJUANA,BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOLOG WASH KIT |
| Generic Name | APPARATUS, AUTOTRANSFUSION |
| Product Code | CAC |
| Date Received | 2020-01-20 |
| Model Number | ATL2001 |
| Catalog Number | ATL2001 |
| Lot Number | 217254960 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MEXICO |
| Manufacturer Address | AV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-20 |