MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I ADULT WITHOUT INTEGRATED FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 70000

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Low Oxygen Saturation (2477)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it yet.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

Description from the customer report: patient on v-av ecls at 1600 hrs-art-fem venous cannulation and int jugular art cannulation activated clotting time -171 seconds.Heparin drip 500 units per hours.Event: at 17:30 hrs blood flow 4lpm/ fio2-100%/ ven sat 80%- sat increase to 95% with increase blood flow to 5lpm; at 21:00 hrs-ven sat 88% and dropping; at 21:30 hrs blood gasses sent art and ven; gas source direct from wall 100% fio2/sweep 5lpm / gasses repeated.Sats dropped to 54% prior to change; oxy changed by 22:00hrs- 4 min interruption in support; sats decreased patient arrested; blood gasses improved after oxygenator change.(b)(4).

Manufacturer Narrative

The product was received for evaluation.A quadrox-i oxygenator was received in the decontamination / complaints laboratory.No clots were flushed out when the oxygenator was flushed with water.The oxygenator was then cleaned with sodium hypochlorite solution.Nothing of note was found during the investigation, and for further tests, the oxygenator was sent to the qa laboratory for performance testing.The product was tested for its o2 and co2 gas exchange and pressure drop performance.All tests were passed, showing that the product is performing to specification.The patient was in a serious condition, and before this case had suffered asystole twice.The customer was sent a list of questions put together by the application therapy manager regarding the case and patient condition, but despite several attempts to obtain additional information within a good faith effort, no response was forthcoming.Consequently, without further information about the case, it is not possible to perform a clinical assessment.The available information related to anticoagulation is not clear, and the anticoagulation regime in place could have promoted clotting, but it is not possible to confirm this.No product malfunction is indicated from the investigation results.A dhr review did not identify any anomalies during production or packaging, and a search of the complaint handling database indicates that there is no systemic issue, as this was the only complaint found in the system.However, the clinical picture is not clear and there remains insufficient information to be able to accurately evaluate this case, or to establish a definitive root cause.

Event Description

(b)(4).

• Brand Name: QUADROX-I ADULT WITHOUT INTEGRATED FILTER
• 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: 5701869
• MDR Text Key: 46662967
• Report Number: 8010762-2016-00369
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2017
• Device Model Number: HMO 70000
• Device Catalogue Number: 701031745
• Device Lot Number: 70108603
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening