MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR WITH INTEGRATES ARTERIAL FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 71000 U #SQUADR

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Device requested; not yet received.

Event Description

According to the customer: oxygenator not oxygenated; co2 not blow off, fio2 75% -po2 53 , co2 38, fio2 90% - po2 74 , co2 38.The customer changed out the oxygenator with a new one during the procedure.No harm to the patient was reported.Please note: the affected oxygenator was delivered to the manufacturer hmt.The oxygenator was built in a hmt set.Hmt is the legal manufacturer of the tubing set.(b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(6).The returned hmo 71000 u #squadrox-i adult + filter was investigated in the laboratory of the manufacturer on 2019-04-11.A visual inspection was performed on the returned hmo 71000 u #squadrox-i adult + filter.The product was cleaned with natrium hypochlorit and no clots were detected.A water cycle on the blood side of the oxygenator was performed.No abnormalities were detected.Reconstructing of the process "oxygenation" as by the customer is not possible in our laboratory, due to unequal conditions.Thus the reported failure could not be confirmed.The reported failure was identified as part of the current risk management file (dms # (b)(4) v13).The mitigations of this reported failure in the ifu as follows: the anticoagulation measures should be checked.An unfiltered gas supply can lead to damage of the hollow fiber membrane, leakage and reduced gas exchange performance.This can lead to inadequate patient support, thrombus formation, hemolysis, hemostasis, and ischemia furthermore the oxygenator performance is restricted if the oxygenator operating position is incorrect or if the gas flow is obstructed.Dhr review was performed on 2019-05-15 and no references found, which are indicating a non-conformance of the product in question.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.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

• Brand Name: OXYGENATOR WITH INTEGRATES ARTERIAL FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8480068
• MDR Text Key: 142644768
• Report Number: 8010762-2019-00092
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2018
• Device Model Number: HMO 71000 U #SQUADR
• Device Catalogue Number: 701067822
• Device Lot Number: 70123437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention