MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-03-22 for HMS PLUS INSTRUMENT 30514 manufactured by Perfusion Systems.
[139560365]
With the information available at this time, medtronic can identify a relationship between the hms plus and the adverse patient outcomes described in the literature. The hms plus was not adequately providing correct information in relation to the infants. As a result, additional heparin was administered which could have potential to the worse outcomes. Date of publish used for incident date. Hms plus model 30514 entered as specific model and serial number were not provided. No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether this event has been previously reported. Citation: gruenwald et al. American college of cardiology (2010) 56, 1794-1802 doi:10. 1016/j. Jacc. 2010. 06. 046 mean patient age of study population used for patient age. Majority gender of study population used for patient gender. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[139560366]
Medtronic received information via literature regarding a trial of individualized heparin and protamine management in infants. All data were collected from a single centre between august 2006 and february 2009. The study population included 90 infants younger than 1 year of age (51 male/ 39 female] who underwent cardiac surgery with cardiopulmonary bypass. During the trial, the medtronic hms plus instrument was used for heparin and protamine management for patients randomised to the treatment group (serial numbers not provided). 33 patients were in the hms i group (original protocol using manufacturer's guidelines) with 16 (48%) randomised to treatment arm. 57 patients were in the hms ii group (modified protocol with increase in protamine dose) with 19 (49%) randomised to treatment arm. In the hms i treatment group, the hms plus instrument was found to underestimate actual laboratory plasma anti-xa levels in infants. This caused an overestimated required dose of heparin. The result was significantly poorer clinical outcomes including greater chest tube volume loss, transfusion requirement, intravascular thrombosis along with greater ventilation time, and longer cccu and hospital stay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2019-00008 |
| MDR Report Key | 8443381 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-22 |
| Date of Event | 2010-11-23 |
| Date Mfgr Received | 2019-02-24 |
| Date Added to Maude | 2019-03-22 |
| 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 | PHYSICIAN ASSISTANT |
| 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 | PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HMS PLUS INSTRUMENT |
| Generic Name | ANALYZER, HEPARIN, AUTOMATED |
| Product Code | JOX |
| Date Received | 2019-03-22 |
| Model Number | 30514 |
| Catalog Number | 30514 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-03-22 |