MAUDE Adverse Event Report: B.BRAUN MELSUNGEN AG PERFUSOR SPACE; PUMP, INFUSION

Catalog Number 8713030

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Tachycardia (2095)

Event Date 07/05/2022

Event Type  Death  

Event Description

As reported by the user facility information by bbm sales organization in singapore: "surgeon claimed pump inaccurate." "b.Braun received a message from gerard (bme manager from gleneagles hospital) on the (b)(6) 2022, 9.30am and attended the case on-site on the (b)(6) 2022, 11.00am b.Braun staff met with gleneagles hospital icu sister-in-charge sister tung with bme manager gerard and were informed that the patient primary physician feel that the pumps were not accurate.B.Braun staff received 8 pumps - article no.8713030 in total.Downloaded device histories were analyzed with sister tung.Article no.8713030 sn (b)(4) was not using drug library but suspected to be infusing noradrenaline (2mg diluted in 50mls) based on matching hospital chartings, suspicions agreed by sister tung (prescribed range dose of 0.01 - 3 mcg/kg/min) article no.8713030 sn (b)(4) was not using drug library but suspected to be infusing adrenaline (2mg diluted in 50mls) based on matching hospital chartings, suspicions agreed by sister tung (prescribed range dose of 0.01 - 0.5 mcg/kg/min) article no, 8713030 sn (b)(4), was using drug library midazolam based on device history article no.8713030 sn (b)(4) was not using drug library but suspected to be infusing morphine based on matching hospital chartings, suspicions agreed by sister tung article no.8713030 sn (b)(4) was not using drug library but suspected to be infusing gtn based on matching hospital chartings, suspicions agreed by sister tung article no.8713030 sn (b)(4) was not using drug library but suspected to be infusing kcl based on matching hospital chartings, suspicions agreed by sister tung article no.8713030 sn (b)(4) was not using drug library but suspected to be infusing propofol 1% based on matching hospital chartings, suspicions agreed by sister tung article no.8713030 sn (b)(4) last use was on (b)(6) 2022.No abnormalities were discovered, device histories match with hospital's records.Hospital bme (mr au) checked and claimed that the pumps were within specifications.According to sister tung report, patient was pronounced dead on the (b)(6) 2022, 10.10pm.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report 400562072.The device history files were read and analyzed.On the day of occurrence could be found two infusions with slow rates.During this infusions, no abnormalities were found.No other abnormalities were found in the device history.A visual inspection was performed.No visible damaged are to located.A functional test was performed.The device passed the self test.A terumo 50ml syringe was inserted, and the pump identified the syringe and it could be selected from the menu.It was possible to put the pump in operation.During the functional test, considerable play was detected at the drive.In addition, the drive was very loud during travel.This indicates a fall or impact damage.Individual inspection (with terumo 50ml): a delivery accuracy measurement according to iec 60601-2-24 was arranged.Here a nominal feed rate of 5 ml/h was chosen.The assessed mean deviation "a" of the second operating hour was measured and resulted in a value of +2,04%.Accuracy of set delivery rate should be ± 2 % according to iec/en 60601-2-24.Individual inspection (with ops 50ml): a delivery accuracy measurement according to iec 60601-2-24 was arranged.Here a nominal feed rate of 5 ml/h was chosen.The assessed mean deviation "a" of the second operating hour was measured and resulted in a value of +1,31%.Accuracy of set delivery rate should be ± 2 % according to iec/en 60601-2-24.The strain gauge pressure measurement and the motor power limitation was checked according to the requirements of the technical safety check.The device met the required values and standards.All measured values were within our specification.A long-term test about 24h was performed.A infusion was started with a terumo 50ml syringe.During this long-term test, no malfunction could be detected.The device was disassembled and the inside was investigated.Inside the device could be found liquid residues.The drive pin from the drive was bent.Based on the damages, the drive will be changed.The complaint could not be confirmed.During the check with the terumo 50 syringe, a slight deviation could be detected, however a impact damage could be detected during the investigation.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: PERFUSOR SPACE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B.BRAUN MELSUNGEN AG; carl- braun strasse 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B.BRAUN MELSUNGEN AG; carl-braun strasse 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15233601
• MDR Text Key: 297972179
• Report Number: 9610825-2022-00337
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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 Catalogue Number: 8713030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1