MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC WITH BIOLINE COATING; PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR

Model Number 70105.0330

Device Problems Partial Blockage (1065); Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2013

Event Type  Injury  

Event Description

It was reported that the customer changed out a quadrox-id pediatric oxygenator due to rising trans-membrane pressures over the first 24 hour period of use.The highest recordable total flow was 1.5 liters with 360 ml flowing to the pt.The pressure drop had increased from 34 to 97 in approximately 24 hours.The pt was reported unaffected and did not suffer any adverse effects from the change-out and was subsequently weaned from extracorporeal support.(b)(4).Reference mfr #8010762-2014-00002.

• Brand Name: QUADROX-ID PEDIATRIC WITH BIOLINE COATING
• Type of Device: PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 3573259
• MDR Text Key: 4035051
• Report Number: 3008355164-2014-00002
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/06/2014,12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2014
• Device Model Number: 70105.0330
• Device Catalogue Number: BEQ-HMOD30000-USA#Q
• Device Lot Number: 70080079
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/01/2013
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/10/2013
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2013
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other