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 2020-01-15 for PERFUSION TUBING PACK M580428M manufactured by Cardiac Surgery Mfg Kerkrade.
[175011179]
Device 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
[175011180]
Medtronic received information that during use, the customer reported that the perfusion pack cardioplegia line came away from the oxygenator and blood leaked onto the floor. Patient had a blood loss of 1400 ml and required 2 units of red blood cells (250 ml). Another perfusion nurse in the theatre noticed that the arterial line had been connected to the wrong place in the oxygenator. They decided to cut the tubing and connect the lines correctly to the connector. Surgeons decided to continue the surgery off-pump with beating heart. Patient was moved to ccu and extubated there the same evening. There was no adverse effect to the patient. The following morning, the patient was mobile and there was no impact from what had happened. The cardioplegia lines are not pre-connected to the oxygenator, which means the customer (perfusionist) connects the lines prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000033-2020-00002 |
| MDR Report Key | 9590360 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-15 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2019-09-20 |
| Date Added to Maude | 2020-01-15 |
| 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 | CARDIAC SURGERY MFG KERKRADE |
| Manufacturer Street | VALKENHUIZERLAAN 16A |
| Manufacturer City | KERKRADE 6466ND |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 6466 ND |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFUSION TUBING PACK |
| Generic Name | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
| Product Code | DWF |
| Date Received | 2020-01-15 |
| Model Number | M580428M |
| Catalog Number | M580428M |
| Lot Number | 216170242 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIAC SURGERY MFG KERKRADE |
| Manufacturer Address | VALKENHUIZERLAAN 16A KERKRADE 6466ND NL 6466 ND |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |