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 2020-02-28 for TUBING PACK M443864C manufactured by Cardiac Surgery Mfg Kerkrade.
[188816627]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188816628]
Medtronic received information that during use, the customer reported the red pigtails tubing component from the perfusion pack was being used on an arterial oxygenator port. The customer was taking a sample from the pigtail tubing and had been checking the connection was tight. On gently bending the tubing, the tubing disconnected from the luer connector connected to the oxygenator. As the patient was flowing at approximately 4 liters per minute, approximately 100mls of blood escaped from the luer connector before the customer could resolve the issue (quickly turned off flows for a brief few seconds - to replace the pigtail). The patient did require 1 unit of red blood cells, but the customer stated that as the patient was already bleeding that they could not confirm the 100ml blood loss added to that clinical decision. The product was used to complete the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000033-2020-00003 |
| MDR Report Key | 9768817 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2019-06-04 |
| Date Added to Maude | 2020-02-28 |
| 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 | TUBING PACK |
| Generic Name | TUBING, PUMP, CARDIOPULMONARY BYPASS |
| Product Code | DWE |
| Date Received | 2020-02-28 |
| Model Number | M443864C |
| Catalog Number | M443864C |
| Lot Number | 217448105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-02-28 |