MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-02-03 for I-STAT ACT KAOLIN CARTRIDGE 03P86-25 manufactured by Abbott Point Of Care.
[66490889]
(b)(4). Apoc labeling will be evaluated during the investigation as pertaining to the event.
Patient Sequence No: 1, Text Type: N, H10
[66490890]
On (b)(6) 2017, abbott point of care (apoc) was contacted by a customer regarding act k cartridge that yielded a result of 204 (secs) on actk cartridge lot# r16314b on a (b)(6) patient. The event occurred on (b)(6) 2017 and the patient was getting a balloon catheter, stent implantation procedure. There was no additional patient information at the time of this report. There was no baseline testing performed prior to administering 5000 ie of heparin. The medical director thought that the result of 204 seconds seemed too low and more heparin was administered. The patient later bled out the groin area, intubated as a result of blood loss. The customer states that return product is not available for investigation. (b)(6). The customer states that the patient was fine. At this time and based on the limited information available, apoc does not suspect a malfunction exits but believes an adverse event occurred. The customer states that the patient was intubated, as a results of a hemorrhagic shock. The investigation is underway.
Patient Sequence No: 1, Text Type: D, B5
[74200579]
Apoc incident #(b)(4). The investigation was completed on (b)(4) 2017. Retain product was tested and functioning according to specification. Return product was not available for investigation.
Patient Sequence No: 1, Text Type: N, H10
[74200580]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245578-2017-00007 |
| MDR Report Key | 6300632 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-02-03 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-04-26 |
| Device Manufacturer Date | 2016-11-09 |
| Date Added to Maude | 2017-02-03 |
| 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 | LINDA MACZUSZENKO |
| Manufacturer Street | 400 COLLEGE ROAD |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6136885949 |
| Manufacturer G1 | ABBOTT POINT OF CARE CANADA LTD. |
| Manufacturer Street | 185 CORKSTOWN ROAD |
| Manufacturer City | OTTAWA, ONTARIO K2H 8V4 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K2H 8V4 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | I-STAT ACT KAOLIN CARTRIDGE |
| Generic Name | ACT KAOLIN CARTRIDGE |
| Product Code | JBP |
| Date Received | 2017-02-03 |
| Model Number | NA |
| Catalog Number | 03P86-25 |
| Lot Number | R16314B |
| Device Expiration Date | 2017-04-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT POINT OF CARE |
| Manufacturer Address | 400 COLLEGE ROAD PRINCETON NJ 085406607 US 085406607 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-03 |