MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 78000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Low Oxygen Saturation (2477)

Event Date 02/20/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the hospital: "(b)(6) years old male undergoing cabg+vsr repair on (b)(6) 2018.Went on cpb and first pao2 (31 minutes after cpb established)was 259.After 161 minute, pao2 dropped to 125 mmhg, fio2 was increased to 0,8.After another 25 minutes, pao2 further dropped to 74 mmhg.Oxygen supply source was immediately checked and evaluated as pre-caution, but arterial blood remained deoxygenated.Oxygenator had to be changed while patient was fully rewarmed but still in asystole." (b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4) importer- (b)(4).Contact person- (b)(6).The lot number of the set was requested at least three times from the ssu, but, they could not reach the exact lot number of the claimed set.Therefore, device history record could not be reviewed.Additionally, the sample was discarded by the hospital.Sap trend search was performed (material (b)(4), similar failure) which came to following results: no additional complaint was recorded.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0%, which is below 1%.Due to this information no systemic issue could be determined.As it is not possible to investigate further in this case, it is not possible to determine a clear root cause for the failure.Based on the insufficient information regarding to complaint, the failure could not be confirmed.The data is 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.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 7553092
• MDR Text Key: 109542863
• Report Number: 8010762-2018-00191
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 78000
• Device Catalogue Number: 701064525
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 08/15/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 55 YR