MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been requested for evaluation, but not yet received.A follow-up medwatch will be submitted if additional information becomes available.

Event Description

The unit was being primed, and customer noticed a leak on the outlet of the oxygenator.With closer observation there seemed to be a crack by the outlet pigtail.The device had not been connected to the patient yet.The oxygenator was cut out and replaced without incident.(b)(4).

Manufacturer Narrative

The product was discarded by the hospital; therefore manufacturer's laboratory investigation was not possible.Trend search: a trackwise trend search was performed for p/n 70105.3824 failure code d-leakage luer outlet side and no additional complaint was found.A sap trend search was performed for p/n 70105.3824 failure code 0105 luer outlet side and one additional complaint was found which is already closed for no product related malfunction confirmed.Due to this information no systemic issue could be determined.Based on this a confirmation of the failure is not possible.Correction: according to the event description the product was exchanged prior to patient use.Corrective action: since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5584878
• MDR Text Key: 43638842
• Report Number: 8010762-2016-00273
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2017
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 70105.3824
• Device Lot Number: 70108123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1