MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for AC3 OPTIMUS IABP NA/EMEA IPN001112 IAP-0700 manufactured by Arrow International Inc..
[185233156]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185233158]
It was reported that the balloon volume was reading 0. The staff stated that the intra-aortic balloon pump (iabp) continued to pump with the screen reset. The staff adjusted the alarm volume when this started. The volume was not noticed for about an hour to an hour and a half, but the patient's pressures did not change. When the volume was adjusted, the iabp did a purge cycle and was reading 40cc. The iabp is working now, and the patient is fine. As a result, the console will be exchanged and send to biomed to be checked. There was no report of patient complications, serious injury or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010532612-2020-00077 |
| MDR Report Key | 9884383 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-03-26 |
| 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 | JONATHAN KIMCHAN |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AC3 OPTIMUS IABP NA/EMEA |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC |
| Product Code | DSP |
| Date Received | 2020-03-26 |
| Model Number | IPN001112 |
| Catalog Number | IAP-0700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |